On (b)(6) 2016, the reporter contacted animas, alleging that the subject pump had no power.This complaint is being reported because the user may be unaware that the pump has lost power, leading to under delivery.There was no indication that the product caused or contributed to an adverse event.
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Follow-up #1: date of submission 10/10/2016 device evaluation: the device has been returned and evaluated by product analysis on 09/14/2016 with the following findings: black box shows evidence unexpected por events.The battery compartment is undamaged, no battery cap was returned, test battery cap was used and it was able to fit securely to the pump -¿ez-prime¿ steps were performed correctly, no power interruption or any eaw occurred during the investigation, unable to duplicate ¿no power¿ complaint.The pump¿s cover was removed, no intermittent condition was found to power pcb.
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