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Model Number 18320 |
Device Problems
Leak/Splash (1354); Premature Activation (1484)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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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 deployed early, indicating a failure of the needle mechanism.Insulin was leaking out during fill.The blood glucose (bg) levels were unaffected.
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Search Alerts/Recalls
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