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Arden's Day Blog

Arden's Day is a type I diabetes care giver blog written by author Scott Benner. Scott has been a stay-at-home dad since 2000, he is the author of the award winning parenting memoir, 'Life Is Short, Laundry Is Eternal'. Arden's Day is an honest and transparent look at life with diabetes - since 2007.

type I diabetes, parent of type I child, diabetes Blog, OmniPod, DexCom, insulin pump, CGM, continuous glucose monitor, Arden, Arden's Day, Scott Benner, JDRF, diabetes, juvenile diabetes, daddy blog, blog, stay at home parent, DOC, twitter, Facebook, @ardensday, 504 plan, Life Is Short, Laundry Is Eternal, Dexcom SHARE, 生命是短暂的,洗衣是永恒的, Shēngmìng shì duǎnzàn de, xǐyī shì yǒnghéng de

Filtering by Tag: Recall

RECALL: Medtronic Infusion Sets

Scott Benner

medtronic-logo.png

From Medtronic

Explanation of the Issue
Medtronic has become aware of recent reports of potential over-delivery of insulin shortly after an infusion set change. Over-delivery of insulin can cause hypoglycemia and in extreme cases, death. Medtronic has received reports of hypoglycemia requiring medical intervention potentially related to this issue.

med.jpeg

Our investigation has shown this can be caused by fluid blocking the infusion set membrane during the priming/fill-tubing process. A membrane blocked by fluid most likely occurs if insulin, alcohol, or water is spilled on top of the insulin reservoir which then could prevent the infusion set from working properly. Infusion sets currently being shipped by Medtronic contain a new and enhanced membrane material that significantly reduces this risk.

To see if your infusion sets are part of the recall please go to this page supplied by Medtronic

https://www.medtronicdiabetes.com/customer-support/product-and-service-updates/notice7-letter

*****
Further Press release


Voluntary Glucagon Recall: GlucaGen

Scott Benner

Hey everyone,

I'm passing on some voluntary recall news from Novo Nordisk. If you have their GlucaGen glucagon kit you may want to read on. The text below is the info that I thought to be pertinent from the press release - the entire release can be found here

Take note of the company's estimation that, "of the 71,215 pens being recalled, four pens could be defective".


Novo Nordisk Inc. issues voluntary nationwide recall of six batches of GlucaGen® HypoKit® (glucagon [rDNA origin] for injection) due to detached needles on the syringe in the kit.

from Novo Nordisk

PLAINSBORO, N.J., Sept. 8, 2016 /PRNewswire/ -- Novo Nordisk Inc. is recalling six batches of the GlucaGen®HypoKit® in the U.S. due to two customer complaints from the UK and Portugal involving detached needles on the syringe with Sterile Water for Injection (SWFI). GlucaGen® HypoKit® is indicated for the treatment of severe hypoglycemia (low blood sugar) in patients with diabetes who are treated with insulin. A syringe with a detached needle cannot be used as prescribed.

Untreated hypoglycemia can eventually lead to unconsciousness and seizures, which can prove fatal. If the blood glucose levels are not quickly restored, continuing hypoglycemia can lead to a decline in brain glucose levels which manifests through a variety of symptoms including cognitive dysfunction, sweating, tremors, convulsion and eventually coma or death.

Novo Nordisk conducted an investigation which showed that a small number (0.006%) of needles could be detached from the syringe in certain batches of GlucaGen® HypoKit®. To protect patient safety, Novo Nordisk is recalling affected batches from wholesalers, pharmacies and patients in the U.S.

It is estimated that out of the 71,215 pens being recalled, four pens could be defective.

This recall includes GlucaGen® HypoKit® batch numbers: 

Batch: FS6X270, Expiry: 09/30/2017
Batch: FS6X296, Expiry: 09/30/2017
Batch: FS6X538, Expiry: 09/30/2017
Batch: FS6X597, Expiry: 09/30/2017
Batch: FS6X797, Expiry: 09/30/2017
Batch: FS6X875, Expiry: 09/30/2017

The affected products were distributed starting February 15, 2016. 

Novo Nordisk is working as quickly as possible and in collaboration with the U.S. Food and Drug Administration (FDA) to recall affected products from the marketplace, including those in the possession of patients. To date, Novo Nordisk is not aware of any known adverse events resulting from the use of the recalled batches.

Patients or caregivers should check the batch number to see if their GlucaGen® HypoKit® is affected. The batch number is printed on the GlucaGen® HypoKit® as indicated below in the red box (Figure 1).

Figure 1. A) GlucaGen® HypoKit® where the batch number is found in the red box, B) close up of the batch number.

If you have a GlucaGen® HypoKit® with one of the above-mentioned batch numbers, call 1-888-840-1137 from Monday to Friday, between 8:30am – 6:00pm Eastern Time, to find out how to return the product.  Novo Nordisk will provide reimbursement for out-of-pocket costs incurred for the purchase for your affected GlucaGen® HypoKit® with proof of purchase. If you received a GlucaGen® HypoKit® through the Novo Nordisk Patient Assistance Program, you will receive a replacement device.

If you are in possession of a GlucaGen® HypoKit® with a batch number NOT mentioned above, the product is not subject to the recall and may be used as prescribed.

Novo Nordisk Inc. is notifying its distributors and customers by letter and phone and is arranging for return of all recalled products.

Adverse reactions or quality problems experienced with the use of this product may be reported to Novo Nordisk by calling 1-800-727-6500.  Patients can also call the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online: www.fda.gov/medwatch/report.htm
Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178. 

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Novo Nordisk is committed to patient safety and delivering high-quality medicines, and is working to take corrective actions and avoid re-occurrence.

Click to enlarge


"Because of your podcast (Juicebox), I have significantly reduced the amount of spikes that I get."

OmniPod Needle Mechanism May Fail to Deploy

Scott Benner

The post title has been edited to remove the phrase "voluntary recall" because I mistakenly used the phrase. This is not a recall, voluntary or otherwise - it is a Field Safety Notification. My apologies to all. - Best, Scott

from Insulet


Insulet Corporation
November 2, 2015
URGENT: Field Safety Notification
OmniPod® Insulin Management System
Certain OmniPod Lots Specified Below
 
Dear Valued Insulet Customer,
Insulet Corporation, the manufacturer of the OmniPod Insulin Delivery System, is committed to keeping you and your healthcare professionals up-to-date in the event there are any issues that arise related to our products.

As part of our product quality monitoring process, we have identified that 15 lots of OmniPod which were distributed in the U.S. had a slight increase in the reported cases in which the Pod’s needle mechanism failed to deploy or there was a delay in the deployment of the needle mechanism. The reported incidence of this product issue in the affected lots is approximately 1%-2%.  Once we recognized this, we corrected the manufacturing process and implemented additional inspection steps.

No serious injuries or deaths have been reported in patients using OmniPod devices from the affected lots.

How do I know if I have affected product? 
This Field Safety Notification affects only the Pods and does not affect the OmniPod Personal Diabetes Manager (PDM). The slight increase was identified in the following lots of Pods:


The lot number is located on the Pod tray lid label, the side of the Pod and on the end of the box of Pods.  

To open a PDF version of the Insulet Announcement - click

To open a PDF version of the Insulet Announcement - click


What is the risk? 
In the event a needle mechanism fails to deploy, the needle will not be inserted and insulin delivery will not begin. The interruption of insulin delivery may cause elevated blood glucose (hyperglycemia), which, if left untreated, can result in diabetic ketoacidosis (DKA). If you believe you have successfully activated your Pod and you experience unexpected elevated blood glucose levels, please consult your healthcare professional.

Upon activation, how do I know if the needle mechanism deployed? 
After you press the Start button on the PDM, you should hear a few soft clicks and then a louder click from the Pod indicating that the needle mechanism has deployed. If you do not hear this within a few seconds after pressing Start, the Pod has failed to deploy. 
You should also feel the insertion of the needle mechanism deployment. The PDM will indicate that the Pod is active and prompt you to check to ensure the cannula is properly inserted (Figure 5-23 in my PDF).  For more information, please see the User Guide.
You should always check the infusion site after insertion to ensure that the cannula was properly inserted. 

When you see the pink slide insert in this position, it means that the cannula is inserted (See figure in my PDF).

The PDM will automatically remind you to check your blood glucose 1.5 hours after each Pod change.  If the cannula is not properly inserted, hyperglycemia may result.
If you experience unexpected elevated blood glucose levels, change your Pod and contact your healthcare provider.You may also call Customer Care at 1-855-407-3729 if you have any questions regarding this Field Safety Notification. 

This voluntary action is being taken by Insulet Corporation with the knowledge of the U.S. Food and Drug Administration (FDA). Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online or by regular mail or by fax.
 
We appreciate how you depend on us and sincerely regret any inconvenience this may cause you. We are focused on delivering the highest level of product quality and your complete satisfaction is our top priority.


Sincerely,
Michael Spears
Vice President, Quality, Regulatory & Clinical Affairs
Insulet Corporation
 

Announcement can be found on the Insulet website with this link.


The Juicebox Podcast is free and available everywhere! iTunes, Stitcher, your favorite podcast app, here on the blog and coming soon to Google Play.

Urgent Product Recall: FreeStyle® Blood Glucose with OmniPod PDM

Scott Benner

Due to the important nature of this information, I'll be posting the entire press release from Abbott's site without their prior permission. I am not sure what prompted this recall but I'm working to find out.

From AbbottDiabetesCare.com

IMPORTANT: URGENT PRODUCT RECALL 
FreeStyle® Blood Glucose Monitoring System

February 19, 2014

Dear Valued OmniPod® Customer,

Recently, it has come to our attention that FreeStyle® Blood Glucose Test Strips may produce erroneously low blood glucose results when using the FreeStyle® blood glucose meter built into the OmniPod® Insulin Management System. Erroneously low blood glucose results that are not recognized may pose significant risks to your health.

Please take the following steps:

1. If you are using the FreeStyle® Blood Glucose Meter built into the OmniPod Personal Diabetes Manager (PDM), you must discontinue use of any FreeStyle® Blood Glucose Test Strips you may have until you obtain replacement strips from Abbott Diabetes Care. To receive replacement strips at no cost contact Abbott Diabetes Care Customer Service at 1-877-584-5159.

2. Continue using your OmniPod Insulin Management System (OmniPod) to deliver your insulin therapy. While waiting for your replacement strips to arrive, use the FreeStyle® Freedom blood glucose meter that you may have previously received with your welcome pack. FreeStyle® test strips when used the FreeStyle® Freedom blood glucose meter will produce accurate blood glucose results. 

If you would like to continue using the OmniPod system to recommend dosing, follow your OmniPod® Insulin Management System instructions for manually entering blood glucose readings. 

As always, control solution should be used to check the performance of your test strips and meter until you receive your replacement test strips. If any reading from a strip appears lower than you would expect or does not seem to match the way you are feeling, you should contact your health care provider immediately. Pay special attention to signs and symptoms of high blood sugar (hyperglycemia). 

Symptoms of high blood sugar may include: Excessive thirst, excessive urination, blurred vision, weakness, nausea, vomiting, and abdominal pain. If you are experiencing any of these symptoms or are not feeling well, contact your health care professional immediately.

3. Abbott Diabetes Care will provide further information when you call on the process to obtain your test strips going forward. 

FreeStyle® Blood Glucose Test Strips are the only strip type that is approved for use with your OmniPod® Insulin Management System. Please read your product information booklet and test strip insert carefully to ensure that you are using the correct test strip type for your OmniPod® Insulin Management system. OmniPod® Insulin Management System is not labeled for use with FreeStyle Lite® Blood Glucose Test Strips.


We recognize the importance of blood glucose testing and are committed to responding quickly to customers' requests for replacement test strips.

We want to assure you that our first priority is you, our customer. We sincerely regret any inconvenience this situation may cause. If you have any further questions, please call Abbott Diabetes Care Customer Service.

Sincerely,

Kelly E. Duffy  Division Vice President, Quality Assurance and Compliance Abbott Diabetes Care

Recall: FreeStyle and FreeStyle Lite Test Strips

Scott Benner

From Abbott Diabetes Website:

 

November 20, 2013
Dear Valued Customer,
Recently, it has come to our attention that certain lots of FreeStyle® and FreeStyle Lite® Blood Glucose Test Strips produce erroneously low blood glucose results when using FreeStyle® Blood Glucose Meters, FreeStyle Flash® Blood Glucose Meters and the FreeStyle® blood glucose meter built into the OmniPod® system. Erroneously low results that are not recognized may pose significant risks to your health.
If you do not use the meters in the photographs below, your blood glucose test results are not affected and you do not need to read any further.
FreeStyle Flash® 
Blood Glucose Meter
 FreeStyle®
Blood Glucose Meter
OmniPod®
Please click here for Abbott's complete announcement that lists affected lot numbers and information about what to do next if you have strips that are part of the recall.