Model Number 18320 |
Device Problem
Positioning Failure (1158)
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Patient Problem
No Information (3190)
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Event Date 12/03/2020 |
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 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 by the patient that the needle mechanism did not deploy as intended during activation.
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Manufacturer Narrative
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The pod was received with the cannula not deployed.Pod download data revealed that it completed first priming prematurely, resulting in early completion of second priming without deploying the needle.Discontinuity was observed in the rotational sensor data, indicating a rotational sensor malfunction.This led to the early completion of priming and contributed to the reported needle mechanism failure to deploy needle.No damages were observed in the device that would cause the rotational sensor malfunction.
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Search Alerts/Recalls
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