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Model Number 19191 |
Device Problems
Material Separation (1562); Material Split, Cut or Torn (4008)
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Patient Problem
Hyperglycemia (1905)
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Event Date 10/19/2022 |
Event Type
malfunction
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Manufacturer Narrative
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According to the complainant the device will not be returned for investigation.We are unable to confirm the damaged 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 while a patient had been wearing a pod between 4 and 24 hours their blood glucose level had rose to 286 mg/dl.The patient reports the pod was leaking during wear.In addition the patient reports upon removal of the pod from the infusions site (arm), the cannula was found to be damaged as it was no longer attached to the pod.As treatment, the patient applied a new pod.
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Search Alerts/Recalls
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