BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3935788 · Received July 15, 2014

    Report

    Report Number
    2531779-2014-20142
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Report Date
    July 1, 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 BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/06/2014 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP¿S BLACK BOX HISTORY SHOWED EVIDENCE OF SHORT BATTERY LIFE ILLUSTRATED WITH DRASTIC VOLTAGE DROPS ON (B)(6)2014. THE PUMP¿S ELECTRICAL CURRENT DRAWS WERE FOUND TO BE OUT OF THE REQUIRED SPECIFICATIONS. THE PUMP¿S ELECTRICAL CURRENT DRAW RETURNED TO SPECIFICATIONS AFTER UNPLUGGING THE CONTINUOUS GLUCOSE MONITOR (CGM) CONNECTOR FROM THE PRINTED CIRCUIT BOARD. AN INTERMITTENT CONDITION WAS FOUND TO THE CGM MODULE DUE TO A COLD SOLDER CONNECTION. THE PUMP¿S ELECTRICAL CURRENT DRAWS RETURNED TO SPECIFICATIONS AFTER RE-SOLDERING THE PIN AND PLUGGING THE CGM CONNECTOR TO THE PRINTED CIRCUIT BOARD.

    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).

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (BATTERY LIFE) 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
    412124 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1