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.(b)(6).
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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 06/14/2016.Device evaluation: the device has been returned and evaluated by product analysis on 06/01/2016 with the following findings: during investigation, there was evidence of a short battery life with a voltage drop leading to a cs 177 alarm.There was moisture corrosion observed in the battery canister and on the battery cap.A leak test failed due to a battery compartment leak.The pump¿s cover was removed and there was no further moisture ingress or any intermittent condition found to the printed circuit board.Unrelated to the original complaint, the battery compartment was found to be cracked.Additionally, the pump powered on to a dim and discolored display.Animas has conducted a review of the device history record for this pump and confirmed that it was operating within required specifications at the time of release.
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Search Alerts/Recalls
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