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 w/ damage) 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 09/29/2016 device evaluation: the device has been returned and evaluated by product analysis on 09/02/2016 with the following findings: black box shows evidence of short battery life on (b)(6) 2016 with drastic 21 counts voltage drop leading to ¿cs128¿ alarm.The battery compartment is cracked at threads on the side; returned battery cap is undamaged and able to fit.Moisture corrosion is observed in the battery canister and on the battery cap, leak test failed due a battery compartment leak.3-¿ez-prime¿ steps were performed correctly; all currents draw are within spec (step30).Unable to duplicate reported ¿short battery life¿ complaint.The pump¿s cover was removed, further moisture corrosion was found to the cgm module.The display lens is cracked along the bottom gray contour.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.(b)(4).
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Search Alerts/Recalls
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