Device Problem
Failure to Prime (1492)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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The pump has not been returned to animas for evaluation.If the device is returned, an evaluation shall be completed and a supplemental report will be filed.No conclusions can be made at this time.
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Event Description
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On (b)(6) 2016, the reporter contacted animas, alleging a prime (load step malfunction) 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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Manufacturer Narrative
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Follow-up #1: date of submission: 03/15/2016.Device evaluation: the cartridge and pump have been returned and evaluated by product analysis on 03/08/2016 with the following findings: the cartridge was returned to animas and a visual inspection of the cartridge was performed.No damage or defects were noted.A fill test and force test were performed with no failures observed.The cartridge force readings were confirmed to be within specifications.During an inspection of the pump, there were multiple ¿no cartridge detected¿ warnings observed in the black box.The load step malfunction was not duplicated during investigation.The pump was opened and there was no evidence of physical damage on the force sensor pins.
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Search Alerts/Recalls
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