Device Problem
Failure to Deliver (2338)
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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.(b)(6).
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Event Description
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On (b)(6) 2016, the reporter contacted animas, alleging a call service alarm (call service alarm issue) issue; 087-yyyyyyy.This complaint is being reported because the reported issue may result in a long term cessation of insulin delivery if the user is unable to resolve the alarm.There was no indication that the product caused or contributed to an adverse event.
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Manufacturer Narrative
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Follow-up #1: date of submission: 08/30/2016.Device evaluation: the device has been returned and evaluated by product analysis on 08/08/2016 with the following findings: a review of the black box and alarm history revealed multiple call service alarms.The pump alarmed with a call service alarm upon the first rewind attempt.A language corruption occurred at a component on the printed circuit board resulting in a call service alarm.
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Search Alerts/Recalls
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