Device Problem
Failure to Prime (1492)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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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.(b)(6).
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Event Description
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On (b)(6) 2016, the reporter contacted animas, alleging a prime (unable to prime) issue.There was no indication that the device caused or contributed to an adverse event.This complaint is being reported because the issue may result in a long term cessation of insulin delivery if the user is unable to resolve the alarm.
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Manufacturer Narrative
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Follow-up #1: date of submission 12/12/2016 device evaluation: the device has been returned and evaluated by product analysis on 11/15/2016 with the following findings: unable to investigate- additional failure prevents adequate investigation.Pump powers on to a hard "cs127" alarm.Multiple loss of prime warnings eaw 162 observed in the black blox /box with low non zero and zero force.Opened pump- reference voltage at pcb component c38 was found to be off spec at.8 voltage.Moisture was also found on component c38.Battery compartment cracked from case seal traveling to grip pad and at case seal to the left side of the grip pad.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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Search Alerts/Recalls
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