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Model Number 18320 |
Device Problem
Material Twisted/Bent (2981)
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Patient Problems
Hyperglycemia (1905); Irritation (1941)
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Event Date 11/24/2020 |
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 near 500 mg/dl while wearing the pod between 4 and 24 hours.When removed from the infusion site (leg), the pod's cannula was found kinked/bent.As treatment for hyperglycemia, insulin was delivered and a water was consumed.
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Manufacturer Narrative
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The received device had the cannula assembly deployed.The exposed portion of the soft cannula was found bent/kinked, although it cannot be determined when or how this damage occurred.Fluid was able to flow through the fluid path with no signs of struggle.Blood was observed on the adhesive pad, however, no evidence was found that would result in bleeding or skin irritation to occur at the infusion site; a root cause could not be determined.No leaks were found during testing, and no other defects or deficiencies were found that would result in a failure of the device to deliver insulin.
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Search Alerts/Recalls
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