Device Problems
Device Displays Incorrect Message (2591); Fail-Safe Problem (2936)
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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 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) 2017, the reporter contacted animas, alleging that the pump emitted a cs 087 call service alarm.There was no indication that the product caused or contributed to an adverse event.This complaint is being reported because the issue may result in a long term cessation of insulin delivery if the user is unable to resolve the alarm.
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Manufacturer Narrative
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Follow-up # 1 date of submission 3/24/2017.Device evaluation: the device has been returned and evaluated by product analysis on 3/06/2017 with the following findings: during testing, the pump was powered on and emitted a cs 069 call service alarm during the rewind step of the investigation.The call service alarm was recorded in the black box data as a cs 087 failure, indicating a language file corruption due to a failed u39 component on the printed circuit board.
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Search Alerts/Recalls
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