On (b)(6) 2016, the reporter contacted animas, alleging a prime (loss of prime) 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 04/14/2016.Device evaluation: the pump has been returned and evaluated by product analysis on 04/04/2016 with the following findings: a review of the black box data showed no evidence of loss of prime.During testing, the pump successfully completed a rewind, load, and prime sequence.The pump was exercised for 24 hours with no loss of prime.The force sensor calibration was found to be within specifications.The complaint was not duplicated during testing.Unrelated to the complaint, the battery compartment was cracked.The audio bolus button cover was torn.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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