Device Problem
Device Stops Intermittently (1599)
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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 power (intermittent power) issue.This complaint is being reported because the reported issue was not resolved with troubleshooting.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 submitted 3/07/2016: a review of the complaint record indicated this complaint was received by animas on 2/25/16, not 2/26/16 as previously reported.
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Manufacturer Narrative
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Device evaluation: the device was returned to animas and evaluated by product analysis on 04/04/2016 with the following results: issue confirmed in history but not duplicated in testing.Pump was exercised with returned battery cap for 24 hours with no reboot, loss of power or call service alarms duplicated.A "intermittent power or cs 052" event was not duplicated during investigation.Black box dates from (b)(6) 2016.Bb data from date of complaint has been overwritten.Current bb shows no evidence of an "intermittent power" event however cs 052/054 errors observed in alarm history on (b)(6) 2016.
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Search Alerts/Recalls
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