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 reported needle mechanism failure or to determine its root cause.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 that the device deployed the cannula correctly.
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The device was received undeployed.The download data shows an 0x12 alarm, , indicating a device reset caused by low voltage, occurred during first prime.The pod was successfully paired with a pdm, completed priming, and delivered a 5u bolus.No alarms were replicated during the rerun.During investigation, all three batteries were measured to have sufficient voltage and shelf mode current was measured to be within specification.No damages or defects were observed that would result in the 0x12 alarm.The root cause of the reported alarm could not be determined.
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