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 04/28/2016 - device evaluation: the pump has been returned and evaluated by product analysis on 04/13/2016 with the following findings: during investigation, a review of the pump¿s black box showed evidence of short battery life with a drastic voltage drop leading to a cs 128 replace battery alarm.A visual inspection of the pump revealed a battery compartment crack between the keypad and the case seal.There was moisture corrosion observed inside the battery canister.A leak test was performed and a battery compartment leak was found.The pump was powered on with no auditory alerts; the battery indicator showed low battery levels with a new battery; short battery life was duplicated.During testing, the ez-prime steps were performed correctly.All current readings were found to be within specification.The pump¿s cover was removed and no further moisture ingress was observed.Further inspection found a broken solder joint on the piezo-circuit.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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