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Model Number 18320 |
Device Problem
Failure to Fire (2610)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/28/2023 |
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.No lot release records were reviewed, as the product lot number was not provided.
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Event Description
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It was reported that the cannula did not deploy, indicating a failure of the needle mechanism.The pod was not worn, and the blood glucose (bg) levels were unaffected.
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Search Alerts/Recalls
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