We've been urgent for more detail from Abbott Diabetes Tending since mid-last-week about its stylish batch of recalls, impacting a huge keep down of customers using FreeStyle mental testing strips and meters — including ALL OmniPod users.

If you haven't detected yet, check into our initial NewsFlash about the recall of their test strips and older FreeStyle and FreeStyle Flash blood sugar meters.

A news release on the Abbott Diabetes press room page details the issue and has includes recommendations from Kelly Duffy, VP of Quality Assurance and Compliancy:

Latterly, IT has come to our attending that FreeStyle Blood Glucose Tryout Strips Crataegus laevigata produce mistakenly low blood line glucose results when victimization the FreeStyle blood sugar cadence built into the OmniPod Insulin Management System. Erroneously low blood sugar results that are non recognized may set significant risks to your health.

In a second consanguine recall, the homophonic is apparently reliable for the FreeStyle Flash and older FreeStyle blood sugar meters (some of which are nary longer ready-made), i.e. they "may farm erroneously low blood line glucose results when victimisation FreeStyle Lite and FreeStyle bloodline glucose test strips."

What we learned from Insulet is that newer models of Abbott glucose meters apparently have the capability to "eliminate the noise" caused by the faulty test strips. But FreeStyle meter models developed earlier — including the meter in the OmniPod (old and newer) system — do not. This is why Abbott is issuing two separate recalls; from their lateral, it's easier to simply upgrade customers to a newer meter model, but since the OmniPod has the meter made-up-in, the solution there is to replace customers' current stores of test strips.

What should you do if you use any of these? Abbott is recommending that you discontinue use of the effected strips and meters straight off, and vociferation for replacements:

For the OmniPod Personal Diabetes Managing director (PDM) — to receive replacement strips at no cost contact Abbott Diabetes Care Client Service at 1-877-584-5159*.

We're being told they'll replace up to 400 strips immediately, and more can be replaced by and by once they cause more supplies stocked up. Customers are being asked to provide the following information: test strip info (fate numbers and expiration), the apothecary's shop you get your test strips from (phone and location), your insurance info, and the phone and address of your Dr..

*Note: we've been trying to get through connected that bloodline for several days; the phone queue line is quite long!

* UPDATED 2/27: Customer Service tells us that the only FreeStyle strips safe to use with Pods are Luck #s 1376759 & 1371831, operating theater those expiring after Grand 2015.

For the FreeStyle Flash or FreeStyle m eters — call Abbott Diabetes Care Customer Table service at 1-888-345-5364 to have Abbott post you a new-sprung FreeStyle-branded m at no charge.

Twofold letters from Abbott and Insulet were sent out via Precedence Overnight FedEx service to all their customers in the finally few years, which was both overdue and undoubtedly quite costly. (Note that the FedEx gasbag Amy received was well-marked "earthsmart C neutral"):

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The letters are pretty generic, however, and don't articulate untold more than what's on the Abbott website.

What surprised us most is the uninteresting burn of getting this data come out online, especially in light of our late post and community discussion about the best way to handle communicating around recalls.

And despite numerous efforts to arrest answers, we've been frustrated that Abbott Diabetes hasn't aired more detail behind this big recall, level days after they did publish a basic notice on their website.

It appears that the current recall is really an enlargement of an Abbott recall that began with 20 lots in late November 2013, and has been under probe for almost troika months now.  Abbott Diabetes Precaution apparently let the FDA know in late Jan that it had distinct to expand the first call up. From there, IT took some weeks to get through all the official channels until word would reach the hoi polloi in reality impacted.

All the while, the great unwashe using these strips and meters were none the wiser that the supplies and devices they were using may cost producing false low readings. Not good, Abbott.

Here's a timeline, as we've been able to ascertain:

  • Unpunctual November 2013 – Abbott Diabetes issued a voluntary recall that included 20 heaps of strips.
  • Late January 2014 – this is when the caller notified the FDA approximately the decision to expand that recall to let in every FreeStyle strips existence used aside OmniPod customers.
  • Feb. 19, 2014 – two "return letters" were posted in Abbott Diabetes Care's online "press way," letting the world know about these potential problems — or at least those who might happen upon that web page.
  • Friday, Feb. 21-Monday, February. 24 – none other client notification occurred, unless you knew to call customer service yourself. Wait times along the phone line were much an hour. Many pharmacies and doctors were still clueless about the recalls, reported to countless anecdotes from PWDs posted online.
  • Monday, Feb. 24 – many people accepted the overnight FedEx letters from Abbott, which included their own informational letter as well as Insulet's. Oddly, the Abbott letter of the alphabet is dated Feb. 14, indicating that it was equipped even earlier than we thought but received away customers at least 10 years later.

Hmm, it's also worth pointing out that the Nov. 27 recall was posted on the organized Abbott news pageboy, while this latter expanded retrieve impacting even more customers was not, and appeared only happening the Abbott Diabetes Manage press room page. Even though technically, these weren't "campaign releases" but customer apprisal letters.

This isn't the first recall of its kind for Abbott Diabetes. Back in 2010, Abbott pulled 359 million test strips from the marketplace in the U.S. and Puerto Rico after discovering a similar problem with erroneous low blood glucose readings. And last spring, Abbott's diabetes device lin recalled FreeStyle InsuLinx meters that were giving people inaccurately high glucose readings.

We were in touch with Abbott's public affairs manager Jessica Sachariason, who was only capable to provide a tiny bit of additional information on this in style call in on behalf of the company, as follows:

DM) What is the exact nature of the problem, making the strips and meters green groceries the "mistakenly low-lying readings"?

ADC) The root cause has been dictated to equal a strip manufacturing process error, which solitary expresses when a strip is misused with a non-practical voltage meter (FreeStyle, FreeStyle Flash, and the FreeStyle m built into the Omnipod system).  The manufacturing error causes a decreased response in the system glucose readings. Meters with applied voltage are non impacted and do not express a decreased response in the system glucose readings.

Have harmful events been according?

There hold been Medical Device Reports (MDRs) filed with the Food and Drug Administration, which are potentially associated with this issue. Abbott is investigation these reports.

What has Abbott done to resolve this issue in the manufacturing or quality control process, to see it doesn't materialize again?

Abbott has implemented extra quality control processes.

What total amount of strips and meters, or more significantly people, are impacted by the recalls?

The user base of the FreeStyle Newsflash Blood Glucose Monitoring system and FreeStyle Rakehell Glucose Monitoring systems represents approximately 1% of our U.S. customer base that use Abbott's FreeStyle meters.

{Editor's note: Most companies keep their customer numbers pool as a closely guarded secret, although it's common in recalls to see an effective act of how many products are beingness recalled.}

When did you ascertain some this?

Following the conclusion of the investigation joined to the November remember, Abbott unregenerate that in the interest of patient refuge to expand the recall.  Abbott proactively contacted the FDA and promptly initiated a product come back in wonder-struck markets and has communicated with all affected parties.

How did you make the number of 400 strips to at first replace for each client?

The health and safe of our patients is our highest priority. Approximately 99 per centum of the U.S. customer base who manipulation Abbott's FreeStyle family of meters are not impacted as they do not apply FreeStyle Flash or FreeStyle Blood sugar Metre systems. After a thorough evaluation of client examination needs and consulting with stakeholders, 400 try strips should substitute a client's stock list of test strips and provide an initial two to 3 month render to the customers. This amount should cover the customer until the customer's succeeding visit to the pharmacy to replenish their next test denudate provision. Owed to these factors, there is no military action required by doctors, pharmacies, and suppliers. If an HCP, chemist's shop or provider has a question, they should contact Abbott's diabetes care customer service and a spokesperson leave provide support.

Why are people being asked to provide doc/insurance information on the client inspection and repair call?

Customers are being asked to provide MD/insurance information systematic to determine the most appropriate route for tense strip replacements.

Although Abbott wasn't able to detailed on anything relating to adverse events when we asked, a quick search through the FDA's database shows a number of reports involving potential issues with FreeStyle strips and meters relating to these recalls. Reading through few of the summaries is precise unnerving. Peculiarly frightening was one harmful event reputation we found from December, in which a physician rumored that it's possible an OmniPod-using PWD may sustain died from ketoacidosis atomic number 3 a result of these falsely rock-bottom BG readings from the integral meter!

Whol of these recollect troubles combined, with the unimpaired botched handling of the Freestyle Sailing master CGM discontinuation in 2009 and 2010 is enough to really shake customers' trust in Abbott Diabetes Care.

We know that product recalls happen, as sure as acts of Divinity. What's Francis Scott Key in that day and age is the need for swift action and transparency away the manufacturers.