Glucose Meter Recall... Deja Vu
Abbott recalled the FreeStyle InsuLinx meter on April 15, as a result of a problem discovered by another meter company's recall a few weeks earlier
- Remember this LifeScan recall toward the end of March?
- We wondered: How does the meter actually know you're 1024, when it only shows you "High" or "Hi" after a certain point? Hmmm...
- Well, on the heels of that LifeScan recall, other companies like Abbott started exploring the issue. And that led to this...
- Deja vu, it seemed...
- We asked for more detail, and this is what we heard from Jeff Christensen, public affairs director for Abbott Diabetes Care:
- When the other company publicly announced a problem with their meter, Abbott conducted an investigation of its own glucose monitoring products, consistent with our protocol when another manufacturer initiates a meter recall. Our company confirmed that all of our blood glucose monitoring products are functioning properly at extremely high glucose levels, except for the FreeStyle InsuLinx. Abbott typically tests meters up to a glucose value of 1000 mg/dL, a glucose level which is rare. When we learned about the other company’s issue, we investigated the matter at higher glucose levels. We found that when the FreeStyle InsuLinx meter's memory reaches 210 (or 1024 mg/dL), it forces a “wraparound” so that the result it provides starts back at zero. In other words any result beyond 1024 mg/dL would record as that result, minus 1024 mg/dL (e.g. 1066 mg/dL – 1024 mg/dL = 42 mg/dL). Results of 1024 mg/dL or greater are not results recorded in the meter’s memory but are actually determined in the lab, because our scientists can determine what the glucose value is at the point when the meter’s memory hits capacity and begins the “wraparound” occurrence. Again, Abbott has provided a software update to resolve the issue, available for download at www.freestyleinsulinx.com/swupdate …. Alternatively, we will send replacement meters to customers immediately upon request at no charge.
- Yep... Deja vu indeed! What do you think about all this?
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