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 pump has not been returned to animas.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.(b)(6).
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Event Description
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On (b)(6) 2016 the reporter contacted animas alleging that the patient experienced high blood glucose (bg) and was not sure if the pump was delivering insulin properly.No bg values and no signs or symptoms of hyperglycemia were reported.The alleged bg excursion does not meet criteria for a serious injury.This complaint is being reported based on the allegation that the pump was not delivering as expected.
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Manufacturer Narrative
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Device evaluation: the device has been returned and evaluated by product analysis on 07/06/2017 with the following findings: a review of the black box showed the data from the date of the complaint had been overwritten.The available daily insulin delivery totals correctly reflected the user's programmed basal rates.The rewind, load, and prime steps were performed successfully.The pump was run for 24 hours and no issues occurred.The pump passed delivery accuracy testing and was found to be delivering within the required range and delivering accurately.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.
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Search Alerts/Recalls
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