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 pump has not been returned to animas for evaluation.If the device is returned, an evaluation shall be completed and a supplemental report will be filed.No conclusions can be made at this time.
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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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Follow-up #1 date of submission 05/16/2016.Device evaluation: the pump has been returned and evaluated by product analysis on 04/29/2016 with the following findings: a review of the black box data showed evidence of short battery life.The battery compartment was observed to be intact.No battery cap was returned with the pump; a test cap was able to fully attach to the pump.The pump¿s current draws were found to be out of specifications.A cold solder connection was found on the continuous glucose monitoring circuit.The circuit was disconnected and the current draws returned to specifications.
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Search Alerts/Recalls
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