On (b)(6) 2016, the reporter contacted animas, alleging a call service alarm (call service alarm issue) issue.It was reported that there was a 069 call service alarm.There was no indication that this issue lead to an adverse event.This is being reported because the issue may result in a long term cessation of insulin delivery if the user is unable to resolve the alarm.
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Follow-up # 1 date of submission 3/06/2017.Device evaluation: the device has been returned and evaluated by product analysis on 2/13/2017 with the following findings: during testing, the pump was powered on and emitted a cs 069 call service alarm during the rewind step of the investigation.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.Unrelated to the initial complaint, it was observed that the battery compartment was cracked, the pump case was cracked between the keypad and the pump seal, and the display screen was dim and discolored.The battery cap and cartridge cap were not returned with the pump and test caps were used to complete the investigation.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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