Device Problem
Inaccurate Delivery (2339)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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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 the pump was not delivering insulin accurately.This complaint is being reported based on the allegation against the delivery function of the pump.
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Manufacturer Narrative
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Follow-up #1; date of submission: 10/17/2016.The device has been returned and evaluated by product analysis on 09/26/2016 with the following findings.The pump's black box data from the date of the event had been overwritten due to continued use of the pump.The available daily insulin delivery totals correctly reflected the user's programmed basal rates.The pump passed a delivery accuracy test with no issues observed.The alleged issue could not be duplicated.
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Search Alerts/Recalls
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