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 been returned to animas.Evaluation has not yet been completed.When evaluation is complete a supplemental report will be filed.No conclusion can be made at this time.
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Event Description
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On (b)(6) 2017, the reporter contacted animas, alleging a prime (loss of 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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Device evaluation: the device has been returned and evaluated by product analysis on 05/09/2017 with the following findings: during investigation, there were multiple loss of prime warnings observed in the black box with low non zero force.The pump was exercised for 24 hours with no loss of prime duplicated.The force calibration passed within specification.Unrelated to the original complaint, the battery compartment was observed to be cracked.(b)(4).
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Search Alerts/Recalls
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