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 a call service alarm (call service alarm issue) issue.It was reported that the pump emitted a cs 069 call service alarm.There is no indication that the product issue 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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(b)(6).
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Manufacturer Narrative
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Follow-up # 2 date of submission 3/27/2017 device evaluation: the device has been returned and evaluated by product analysis on 3/07/2017 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.Unrelated to the initial complaint, it was observed that the battery compartment was cracked.The battery cap was not returned with the pump and a test cap was used to complete the investigation.(b)(4).
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Search Alerts/Recalls
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