Providers who sell, use or recommend the Freestyle InsuLinx Blood Glucose Meter are being encouraged by the meter’s maker, Abbott Diabetes Care, to heed the device’s recall issued by the company on April 15.
According to Abbott, the device has a known tendency to display and store incorrect test results when reading particularly high blood glucose levels of 1024 mg/dL and above (e.g., for a blood glucose value of 1066 mg/dL, the meter will display and store a value of 42 mg/dL (1066 mg/dL – 1024 mg/dL = 42 mg/dL).
Regardless of the fact that blood glucose levels of 1024 mg/dL or higher are characterized as extremely rare, when such an event does occur it requires immediate medical attention. Thus, if the Freestyle device does mark the instance at a lower glucose level, a possible fatal delay in identification and treatment can transpire.
Those in possession of a Freestyle InsuLinx Blood Glucose Meter are advised by Abbott to do the following:
- You can access a software update to resolve the issue at www.freestyleinsulinx.com/swupdate. The software update will allow you to maintain settings and historical data on your meter.
- You can contact Abbott Diabetes Care Customer Service at 1-866-723-2697 to expedite return and replacement of your FreeStyle InsuLinx meter at no charge. Replacements are available, and Abbott will send a meter to you immediately upon request.
Moreover, all healthcare professionals with Freestyle InsuLinx Blood Glucose Monitoring Kits “are advised to immediately discontinue dispensing them to your patients. To arrange for product return and replacement, please call Abbott Diabetes Care customer service at 1-866-723-2697. While we are notifying patients directly, we also request your assistance in sharing this information with your patients who use the FreeStyle InsuLinx Meters.”
At this time, the company reports that no other Abbott Diabetes Care products are effected by the issue.
More information about the recall can be found here.