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) 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 4/22/2016.Device evaluation: the device has been returned and evaluated by product analysis on 04/11/2016 with the following findings: a review of the pump¿s black box revealed evidence of an unacknowledged cs 162 (loss of prime) following a cs 147 (occlusion alarm).The pump powered with the returned battery cap.The battery cap was able to fully tighten.The current draws were within specification.The ¿battery life¿ issue was not duplicated during investigation.The pump case was removed and there was no evidence of moisture or loose components inside the pump.Unrelated to the original complaint, the battery compartment was observed to be cracked.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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