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 04/12/2016 device evaluation: the pump has been returned and evaluated by product analysis on (b)(4) 2016 with the following findings: a review of the black box data showed a partially discharged battery being installed on (b)(6) 2016 following a cs 052 and 054 error.A visual inspection of the pump showed that the battery compartment was cracked.The returned battery cap was able to fully tighten on to the pump and maintain an electrical connection.The pump¿s current draws measured within specifications.The pump cover was opened and a cold solder connection was found on the continuous glucose monitoring board.
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Search Alerts/Recalls
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