BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 6215491 · Received December 30, 2016

    Report

    Report Number
    2531779-2016-35063
    Event Type
    Malfunction
    Date Received
    December 30, 2016
    Report Date
    December 9, 2016
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    OYC
    UDI-DI
    10840406100044
    PMA / PMN Number
    P130007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 12/09/2016 WITH THE FOLLOWING FINDINGS: INVESTIGATION REVEALED A CRACK IN THE BATTERY COMPARTMENT. (B)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A CRACK IN THE BATTERY COMPARTMENT. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 12/09/2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    866133 ANIMAS VIBE INSULIN INFUSION PUMP OYC ANIMAS CORPORATION 10840406100044

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR