The device has not been returned/received to date.If the device is received, a supplemental report will be submitted with the investigation results.We are unable to confirm the bent cannula or to determine if it could have contributed to the reported hyperglycemia.Lot release records were reviewed and the product lot met all acceptance criteria.Specifically, a pod is paired to a pdm and put through simulated use testing including confirming the blue soft cannula is inspected for any damage.
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It was reported the patient's blood glucose level was "high" (>27.8 mmol/l,>500 mg/dl).The pod was worn between 4 and 24 hours on the abdomen.It was noted that the cannula was bent.As treatment for the hyperglycemia, correctional boluses were made, an increased basal, and a new pod was applied.
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