Model Number 18320 |
Device Problem
Material Twisted/Bent (2981)
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Patient Problems
Hyperglycemia (1905); Pain (1994)
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Event Date 04/07/2023 |
Event Type
malfunction
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Manufacturer Narrative
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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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Event Description
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It was reported that the patient's blood glucose levels reached 454 mg/dl with ketones of 3.8.The pod was worn between 37 and 48 hours on the hip/buttocks.It was noted that the cannula was bent.Hyperglycemia treated with pen correction.
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Manufacturer Narrative
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The exposed portion of the soft cannula was observed to be bent.During the investigation, the bend did not prevent fluid from exiting the distal tip of the soft cannula.The data downloaded from the device did not show any timeouts or drive stalls during the run.Although the cannula was damaged, the timing and cause of the damage is unknown.
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Search Alerts/Recalls
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