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Model Number 18320 |
Device Problem
Retraction Problem (1536)
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Patient Problem
Hyperglycemia (1905)
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Event Date 04/24/2023 |
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 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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Event Description
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It was reported that the needle did not retract, after wearing the pod between 5 and 24 hours, indicating a failure of the needle mechanism.The blood glucose (bg) levels rose up to 19.1 mmol/l (343.8 mg/dl).
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Search Alerts/Recalls
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