BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 6053631 · Received October 25, 2016

    Report

    Report Number
    2531779-2016-29595
    Event Type
    Malfunction
    Date Received
    October 25, 2016
    Report Date
    October 13, 2016
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    MDS
    UDI-DI
    10840406100082
    PMA / PMN Number
    P130007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/13/2016 WITH THE FOLLOWING FINDINGS: INVESTIGATION REVEALED A CRACK IN THE BATTERY COMPARTMENT AT THE CASE SEAL. THE AUDIO BOLUS BUTTON COVER WAS OBSERVED TO BE DAMAGED AND PUNCTURED; THE AUDIO BOLUS BUTTON RESPONDED APPROPRIATELY DURING INVESTIGATION. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. (B)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A CRACK IN THE BATTERY COMPARTMENT AT THE CASE SEAL. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 10/13/2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705489 ANIMAS VIBE INSULIN INFUSION PUMP MDS ANIMAS CORPORATION 10840406100082

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR