BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 6012998 · Received October 9, 2016

    Report

    Report Number
    2531779-2016-27885
    Event Type
    Malfunction
    Date Received
    October 9, 2016
    Report Date
    September 14, 2016
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    OYC
    UDI-DI
    10840406100044
    PMA / PMN Number
    P130007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION: 11/29/2016. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 11/01/2016 WITH THE FOLLOWING FINDINGS: THE BATTERY COMPARTMENT WAS CRACKED AT THE THREADS ON THE SIDE AND BELOW THE GRIP PAD. THE RETURNED BATTERY CAP WAS UNDAMAGED AND IT WAS ABLE TO FIT. MOISTURE CORROSION WAS OBSERVED IN THE BATTERY CANISTER. THE PUMP WAS UNABLE TO POWER UP AND WAS COMPLETELY UNRESPONSIVE DUE TO THE MOISTURE CORROSION.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS BUT NOT YET EVALUATED. WHEN THE EVALUATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE REPORTER CONTACTED ANIMAS, ALLEGING THAT THE PUMP HAD NO POWER. 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
    664667 ANIMAS VIBE INSULIN INFUSION PUMP OYC ANIMAS CORPORATION 10840406100044

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR