BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 4781181 · Received May 19, 2015

    Report

    Report Number
    2531779-2015-16523
    Event Type
    Malfunction
    Date Received
    May 19, 2015
    Report Date
    May 5, 2015
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    P130007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6)2015 WITH THE FOLLOWING FINDINGS: INVESTIGATION REVEALED A CRACK IN THE BATTERY COMPARTMENT. UNRELATED TO THIS ISSUE, INVESTIGATION REVEALED THAT THE AUDIO BOLUS BUTTON WAS MISSING FROM THE PUMP. (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 (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325959 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1