Device Problem
Inaccurate Delivery (2339)
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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 device 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) 2016, the reporter contacted animas and alleged the pump had a history settings(inaccurate delivery) complaint.There was no allegation of an adverse event.This is being reported there is an allegation against the delivery function of the pump.
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Manufacturer Narrative
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Device evaluation: the device has been returned and evaluated by product analysis on 12/06/2016 with the following findings: the last basal delivery was on (b)(6) 2016 and the last bolus delivery was a 10.05u bolus on (b)(6) 2016 at 13:51.The recorded total daily doses added up correctly and reflected the user's programmed basal rates.The pump passed a delivery accuracy test with no delivery defects found.The pump was found to be delivering within the required range and delivering accurately.The alleged issue could not be duplicated.
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Search Alerts/Recalls
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