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 05/31/2016 with the following findings: during investigation, there was evidence of a short battery life with a voltage drop leading to a ¿cs 177¿ lower battery warning.The battery compartment and battery cap were found to be undamaged and able to fit securely.There was moisture corrosion observed in the battery canister and on the battery cap.The pump passed a leak test.The pumps alarmed with a ¿cs 128¿ replace battery alarm upon confirming the ¿verify¿ screen.The reported short battery life complaint was duplicated.The pump¿s cover was removed and there was no further moisture ingress or intermittent condition found to the printed circuit board.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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