Insulet identifies potential inaccuracy

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Friday, February 14, 2020

ACTON, Mass. – Insulet has announced a voluntary medical device correction for its Omnipod DASH Personal Diabetes Managers. As part of an ongoing monitoring process, the company found that PDMs may suggest an inaccurate bolus amount based on a blood glucose value that is more than 10 minutes old when the user does not exit the bolus calculator as designed or when a system alarm interrupts a bolus calculation. No injuries have been reported and the Omnipod DASH is safe to use. All affected Omnipod DASH users are being notified by email and local mail, and replacement devices will be made available starting in March. Additional information can be found at www.omnipod.com.