On (b)(6) 2016, the reporter contacted animas, alleging a prime (loss of prime) issue.It was reported that the pump repeatedly emitted loss of prime warnings despite cartridge changes.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 # 2 date of submission 04/22/2016-device evaluation: the pump has been returned and evaluated by product analysis on 04/04/2016 with the following findings: 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.A review of the pump black box data revealed multiple loss of prime warnings associated with low, non-zero force readings.During testing, the pump was exercised for 24 hours and the rewind, load, and prime steps were completed successfully with no duplicated loss of prime warnings.The force sensor calibration measured within specifications.Evidence of the complaint was found in the black box data; however, the complaint was not duplicated.Unrelated to the complaint, the battery compartment was observed to be cracked.
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