BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3844805 · Received June 3, 2014

    Report

    Report Number
    2531779-2014-15587
    Event Type
    Malfunction
    Date Received
    June 3, 2014
    Report Date
    May 27, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    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. (B)(6).

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 07/18/2014. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/10/2014 WITH THE FOLLOWING FINDINGS: THE ISSUE WAS CONFIRMED IN HISTORY BUT NOT REPRODUCED IN TESTING. BLACK BOX REVIEW SHOWS UNUSUAL VM VOLTAGES DROPS LEADING TO THE ALARM ON 05/25/2014. ALL CURRENTS READING ARE WITHIN SPECIFICATION AND NO SHORT BATTERY LIFE WAS DUPLICATED DURING THE INVESTIGATION. NO INTERMITTENT CONDITION WAS FOUND TO THE POWER CIRCUIT.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE DISTRIBUTOR CONTACTED ANIMAS, ALLEGING THAT THE BATTERY LIFE WAS NOT LASTING AS LONG AS EXPECTED. 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
    324844 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1