BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 4220322 · Received November 3, 2014

    Report

    Report Number
    2531779-2014-31178
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Report Date
    October 15, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 12/20/2014 WITH THE FOLLOWING FINDINGS: VISUAL INSPECTION REVEALED MOISTURE IN THE BATTERY COMPARTMENT. THE PUMP WAS UNABLE TO POWER ON AND WAS COMPLETELY UNRESPONSIVE DUE TO THE MOISTURE. THE COMPLAINT OF A SUSPEND ISSUE COULD NOT BE INVESTIGATED TO INABILITY TO POWER ON THE PUMP. (B)(4).

    Additional Manufacturer Narrative · 1

    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. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A HISTORY/SETTINGS (SUSPEND) ISSUE. REPORTEDLY, THERE WAS NO EVIDENCE OF AN ALARM OCCURRING AT THE TIME OF THE SUSPEND ISSUE AND NO EVIDENCE OF USE ERROR TO EXPLAIN THE ALLEGED SUSPEND 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    704145 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR