Device Problems
Crack (1135); 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 with damage) issue.The battery compartment reportedly was cracked.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: 04/13/2016.Device evaluation: the device has been returned and evaluated by product analysis on 03/30/2016 with the following findings: a review of the black box revealed evidence of short battery life with drastic voltage drops leading to a ¿call service (cs) 128¿ alarm on (b)(6) 2016.During testing the ¿ez-prime¿ steps were performed correctly; all currents draws were within specification.The reported ¿short battery life¿ complaint was not duplicated.The pump¿s cover was removed; there was no moisture ingress or any intermittent conditions found to the pcb or to the cgm module.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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