BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 6019992 · Received October 12, 2016

    Report

    Report Number
    2531779-2016-28223
    Event Type
    Malfunction
    Date Received
    October 12, 2016
    Report Date
    September 21, 2016
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    UDI-DI
    10840406100051
    PMA / PMN Number
    P130007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 11/08/2016 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX INDICATED REBOOTS HAD OCCURRED. VISUAL INSPECTION REVEALED THAT THE BATTERY COMPARTMENT WAS CRACKED, THE BATTERY COMPARTMENT THREADS WERE STRIPPED, AND THE BATTERY CAP THREADS WERE STRIPPED. THE BATTERY CAP WAS UNABLE TO MAINTAIN ELECTRICAL CONNECTION AND REBOOTS WERE DUPLICATED. REBOOTING ALSO OCCURRED USING A TEST BATTERY CAP.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (WITH DAMAGE) ISSUE. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE USER MAY BE UNAWARE THAT THE PUMP HAS LOST POWER, LEADING TO UNDER DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675443 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION 10840406100051

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR