Follow-up #1: date of submission 03/15/2016 device evaluation: the device has been returned and evaluated by product analysis on (b)(6) 2016 with the following findings: during testing, the pump was powered on and emitted a cs 069 call service alarm immediately upon attempting a rewind step.The call service alarm was recorded in the black box data as a cs 087 failure, indicating a language file corruption due to a failed u39 component on the printed circuit board.
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On (b)(6) 2016, the reporter contacted animas, alleging a call service alarm (call service alarm issue) issue.It was noted that the pump emitted a cs 069 service alarm.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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