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.
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Event Description
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On (b)(6) 2016, the reporter contacted animas, alleging that there were loss of prime warnings.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.There was no indication that the product caused or contributed to an adverse event.
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Manufacturer Narrative
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The device has been returned and evaluated by product analysis on 1/31/2017 with the following findings: there were multiple loss of prime alarm warnings observed in the black box history associated with low non-zero force.The pump was exercised for 24 hours and the loss of prime issue was not duplicated.The force sensor calibration passed within specification.Unrelated to the initial complaint, it was observed that the battery compartment had two cracks.
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Search Alerts/Recalls
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