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Model Number 18320 |
Device Problem
Activation, Positioning or Separation Problem (2906)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/18/2023 |
Event Type
malfunction
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Event Description
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A patient reports while wearing a pod between 24 and 36 hours the pods pink slide did not move forward when the pod was activated; this indicates a needle mechanism failure occurred.The patients reported blood glucose level was 220 mg/dl.
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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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Search Alerts/Recalls
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