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 a history/settings (inaccurate delivery) issue.There was no additional information available for this complaint.There was no indication that the product caused or contributed to an adverse event.This complaint is reportable as there is an allegation against the delivery function of the pump.
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Manufacturer Narrative
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Follow-up #1: date of submission 05/25/2016.Device evaluation: the device has been returned and evaluated by product analysis on 05/06/2016 with the following findings: the last basal delivery was on (b)(6) 2016.The pump history revealed that the pump was manually suspended on (b)(6) 2016 at 10:37 and manually resumed at 10:46.The last bolus delivery was a 0.65 unit bolus on (b)(6) 2016 at 10:49.The total daily insulin delivery correctly reflected the user's programmed basal rates.The pump passed the delivery accuracy test and was found to be delivering within required range and delivering accurately.There were no delivery interruptions or any errors, alarms or warnings that occurred during the investigation.The reported inaccurate delivery complaint was unable to be duplicated during testing.Unrelated to the complaint, the battery compartment was found to be cracked on the side from the threads to cover.
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Search Alerts/Recalls
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