Device Problem
Battery Problem (2885)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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The device has been returned to animas.Evaluation has not yet been completed.When evaluation is complete a supplemental report will be filed.No conclusion can be made at this time.(b)(4).
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Event Description
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On (b)(6) 2016, the reporter contacted animas, alleging a power (battery life) issue.This complaint is being reported because the reported issue was not resolved with troubleshooting.There was no indication that the product caused or contributed to an adverse event.
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Manufacturer Narrative
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The device was returned and evaluated by product analysis on 04/22/2016 with the following findings: review of the pump¿s black box revealed evidence of a shortened battery life.The pump successfully completed a prime sequence without issue or alarm.The pump¿s power draws were found to be above specification.Moisture was observed on the pump¿s power circuit.Unrelated to the complaint, a battery compartment crack and battery compartment moisture were observed.The pump failed leak testing at the battery compartment crack.(b)(4).
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Search Alerts/Recalls
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