On (b)(6) 2016, the reporter contacted animas, alleging a prime (unable to prime) issue.There was no indication that the product caused or contributed to an adverse event.This issue is being reported because it 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 02/10/2017.Device evaluation: the device has been returned and evaluated by product analysis on 01/20/2017 with the following findings: a review of the black box showed multiple loss of prime warnings with low non zero and zero force, and no cartridge warnings.The rewind, load, and prime steps were performed successfully.The pump was exercised for 24 hours and the loss of prime and load step malfunctions were not duplicated.The force calibration testing passed.The pump opened to find no defect found.Unrelated to the original complaint, the battery compartment was cracked from the case seal traveling to the grip pad, and at the case seal to the left side of the grip pad.
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