On (b)(6) 2016, the reporter contacted animas, alleging a power (damage with moisture ingress) 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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Follow-up #1: date of submission 10/06/2016.Device evaluation: the device has been returned and evaluated by product analysis on 09/13/2016 with the following findings: the battery compartment is cracked at threads on the side, returned battery cap is worn at the top slot, but threads are undamaged, the cap is able to fit to maintain electrical connection.Moisture corrosion is observed in the battery canister and on the display screen inside the pump.The pump is unable to power up and it¿s completely unresponsive due moisture damage.Unable to verify steps, reported ¿power¿ complaint is duplicated.The pump¿s cover was removed, further moisture corrosion was found to the cgm module and all over the pcb.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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