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.(b)(6).
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Event Description
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On (b)(6) 2017, the reporter contacted animas alleging a call service alarm (cs 052/053/054/055 sleep) issue.It was reported that the pump emitted a cs 052 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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Follow-up # 1 date of submission 3/28/2017 device evaluation: the device has been returned and evaluated by product analysis on 3/08/2017 with the following findings: the black box and alarm history showed evidence of cs 052 and cs 054 call service alarms.The pump¿s ¿ez-prime¿ steps were performed correctly and no alarms or any errors, alarms or warnings occurred during the 24 hour duration test.The investigation was unable to duplicate the initial ¿call service alarm¿ complaint.The pump was opened and there were no defects found.(b)(4).
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Search Alerts/Recalls
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