Sam Brusco, Associate Editor11.07.22
On October 17 Insulet announced a Medical Device Correction for all Omnipod DASH personal diabete managers (PDMs) distributed globally. The action was taken voluntarily with FDA and other regulatory agencies’ knowledge.
Insulet received reports of PDM battery issues including battery swelling and leakage, and extreme overheating in rare cases that resulted in fires. The company’s investigation found the Omnipod DASH PDM has increased risk of malfunction if overcharged beyond the maximum voltage.
50 complaints have been reported, with no serious injuries or deaths reported thus far.
Insulet identified an update to resolve the issue and aims to start shipping updated Omnipod DASH PDMs to current customers in the coming months.
“Safety is our top priority, and we have been urgently addressing this issue,” Michael Spears, Insulet’s senior VP of regulatory affairs and compliance told the press. “We are committed to helping our customers navigate the replacement process and address any concerns they have. We are confident that a software update will resolve this issue.”
The correction does not affect the Omnipod DASH Pods, insulin management system, or Omnipod 5 automated insulin delivery system.
Insulet received reports of PDM battery issues including battery swelling and leakage, and extreme overheating in rare cases that resulted in fires. The company’s investigation found the Omnipod DASH PDM has increased risk of malfunction if overcharged beyond the maximum voltage.
50 complaints have been reported, with no serious injuries or deaths reported thus far.
Insulet identified an update to resolve the issue and aims to start shipping updated Omnipod DASH PDMs to current customers in the coming months.
“Safety is our top priority, and we have been urgently addressing this issue,” Michael Spears, Insulet’s senior VP of regulatory affairs and compliance told the press. “We are committed to helping our customers navigate the replacement process and address any concerns they have. We are confident that a software update will resolve this issue.”
The correction does not affect the Omnipod DASH Pods, insulin management system, or Omnipod 5 automated insulin delivery system.