BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 4243560 · Received November 11, 2014

    Report

    Report Number
    2531779-2014-32201
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Report Date
    October 24, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 11/18/2014 WITH THE FOLLOWING FINDINGS: THE PUMP POWERED ON TO A BLANK SCREEN. THE PUMP CASING WAS OPENED, AND THERE WAS EVIDENCE OF MOISTURE OBSERVED ON THE OLD DISPLAY FLEX AND CONTACTS.

    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 THAT THE DISPLAY SCREEN CHANGED FONT AND THEN FADED AWAY TO A BLANK SCREEN. REPORTEDLY, THE PATIENT CHANGED THE BATTERY AND TURNED THE PUMP BACK ON, BUT THE DISPLAY REMAINED BLANK. THE REPORTER NOTED THAT THE PUMP¿S AUDIBLE FEATURES WERE FUNCTIONAL AFTER THE BATTERY CHANGE. THE ISSUE REPORTEDLY REMAINED UNRESOLVED AFTER TWO BATTERY CHANGES. 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
    726911 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1