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 cartridge 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 (loss of prime) issue.There was no indication that the product caused or contributed to an adverse event.This complaint is being reported because the reported issue may lead to under delivery of insulin.
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Manufacturer Narrative
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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.Device evaluation: the device has been returned and evaluated by product analysis on 02/14/2017 with the following findings: multiple loss of prime warnings with low non zero and zero force were observed in the black box.The pump was exercised for 24 hours without loss of prime duplicated.Force calibration passed.The pump was opened with no damage, defect or contamination found inside the pump.Unrelated to the original complaint, the battery compartment was noted to be cracked.
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Search Alerts/Recalls
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