On (b)(6) 2019, the reporter contacted animas, alleging a call service alarm (cs 064) issue.It was reported that the pump emitted multiple cs 064 call service alarms.There was no indication that the product caused or contributed to an adverse event.This complaint is being reported because this issue may result in a long term cessation of insulin delivery if the user is unable to resolve the alarm.
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Device evaluation: the device has been returned and evaluated by product analysis on 14-jan-2020 with the following findings: a review of the pump¿s black box and alarm history showed evidence of a call service 064 alarm.During testing, the pump successfully completed the rewind, load, and prime steps without any call service alarms, warnings or issues.The pump successfully delivered a 10 unit normal bolus during testing without any issue or call service alarms.The pump cover was removed and there was evidence of moisture damage to the motor flex connector and surrounding components.The original complaint of a call service alarm issue was noted in the pump history but unable to be duplicated during investigation.
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