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Model Number PT-000010 |
Device Problems
Overheating of Device (1437); Battery Problem (2885)
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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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Manufacturer Narrative
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A technical assessment of the device design identified the root cause of the thermal event to be the dash pdm charging voltage exceeding the battery specification, defined as overcharging.Field safety corrective action 9056196-10/11/2022-001-c has been initiated by insulet corporation.The device will not be returned for investigation.
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Event Description
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It was reported by the patient that the omnipod personal diabetes manager (pdm) battery is expanding, swelling, and giving off excessive heat.
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Search Alerts/Recalls
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