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Model Number 19191 |
Device Problems
Failure to Fire (2610); Communication or Transmission Problem (2896)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/19/2023 |
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 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 pod's cannula did not deploy indicating a needle mechanism failure.It was also reported that the patient was trying to give bolus when there was a pod communication error.As treatment, the patient successfully activated a new pod.The old pod was discarded.
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Search Alerts/Recalls
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