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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Device evaluation: the pump has been returned and evaluated by product analysis on 03/11/2016 with the following findings: a review of the pump¿s black box showed evidence of multiple loss of prime warnings ((b)(4)) with low non-zero force.During testing, the pump successfully completed the rewind, load, prime sequence with no loss of prime warnings occurring.The pump was exercised for 24 hours with no loss of prime occurring.The force sensor calibration was found to be within required specification.The loss of prime issue was shown in the pump history but was not duplicated during investigation.
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