Urgent Product Recall: FreeStyle® Blood Glucose with OmniPod PDM

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

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.

Bermuda Triangle

Last week around eleven in the morning, Arden texted from school to say that it was lunch time and she couldn't get any of her test strips to work. "I've tried five and they've all errored", her text read. 

No problem I thought, "What's your CGM say?"

"???", Arden replied.

We found that Arden could still deliver insulin with her OmniPod PDM so we bolused for lunch in the blind and I told Arden that I was leaving to bring her a backup meter. On the way to the school I spoke with OmniPod customer service (Picked up on the first ring!) and they suggested that I try a new vial of test strips. The CSR finished the conversation by saying that if the test strips weren't the issue, they would happily overnight us a new PDM.

I met Arden in the office a few moments later and we tested successfully with the new strips. The CGM sensor however, was toast, so we changed our testing strategy slightly and synched our reminder alarms. Arden went back to lunch and we managed the remaining four hours of the day the ole fashion way... with a meter.

In all of the years that Arden has had diabetes, this is the first time we've experienced a total and simultaneous loss of the ability to quantify her BG. Even though the timing couldn't have been worse, I never felt frazzled and I can only attribute that calm to having so much experience. I'm quite certain that this moment would have given me an aneurysm five years ago. 

Before I say this next bit, I want to remind you that I am not a medical professional and that the things that I share on Arden's Day are never meant as advice. There is a disclaimer at the bottom of the page if you'd like to read it. I gave Arden her lunchtime insulin in this situation without testing or the benefit of a CGM based on a number of factors. Time of day as it relates to her last bolus, we spoke about how she felt at length, based on historical data - Arden's BGs at this time of day over the week, the fact that she was going to immediately begin eating and I would be there with a new meter and strips in less than 10 minutes. I would never bolus without knowing the state of her BG in a normal situation.

We swapped Arden's DexCom G4 sensor (It had done more than its fair share... if you get my drift) when she arrived home and we were back on the path of technology based diabetes care, by dinner time. The PDM/meter has not given us a problem since, so I'm chalking this all up to an anomaly caused by faulty strips - but who knows.

FDA clears Freestyle test strips for use with OmniPod

 

"The FDA has notified the company that the new Abbott Freestyle test strip has been cleared for use with the OmniPod," Insulet confirmed in an email to MassDevice. "The companies are in the midst of updating the product label and will be communicating with customers once that has been completed, hopefully next week."

It's official, after more then a year and I can only imagine how much cost to taxpayers, the FDA finally has said that we can use Abbott's butterfly test strips in our OmniPod PDMs.

I'm not all that excited and am about to be a bit snarky about this announcement because I figured this out over a year ago for free and it only took me two days.

I completely understand and support that medical devices, equipment and the like need to be safe, accurate and durable but come on - test strips? I asked myself last year, "why would Abbott develop and manufacture a test strip that wouldn't work with their business partner's testing devices". I found the common sense answer to simply be, "of course they wouldn't do that". Then I conducted my own test and began using the strips with Arden's PDM in December of 2010, we have never looked back.

I'd like to congratulate the FDA on once again turning something simple into a train wreck, you guys are nothing if not consistent. Maybe now they'll (FDA) have time to clear Insulet's latest OmniPod design, from what I understand it's being held up because the "documentation can be confusing". To be clear, I've seen the documentation, used the new pods and not only couldn't the documentation be any simpler but it's about 99% the same as the current generation's instructions. In my opinion the new OmniPod design is being held up because of bureaucratic and political BS.

Our representatives in D.C. love to say that business should allowed to thrive but they'll take any chance to stand in it's way. Insulet is not a huge or rich company. They make a wonderful product that every day helps countless people live easier and more healthy lives. I'd very much like to see the FDA give them a chance to make a profit so that their amazing insulin pump can be around until type I diabetes is cured. Hopefully that cure, when discovered, won't be held up by the FDA forever...

I assume that most of you, because of necessity, have already implemented the "new" strips but just in case you were waiting for official word, you can find it here it's entirety.

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Update on 2012-01-12 15:39 by Scott Benner

Insulet has posted a link to updated information.