BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 6967337 · Received October 20, 2017

    Report

    Report Number
    2531779-2017-24430
    Event Type
    Malfunction
    Date Received
    October 20, 2017
    Report Date
    September 23, 2017
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    OYC
    UDI-DI
    10840406100235
    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 09/23/2017 WITH THE FOLLOWING FINDINGS: INVESTIGATION REVEALED TWO BATTERY COMPARTMENT CRACKS. (B)(6).

    Description of Event or Problem · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. INVESTIGATION REVEALED TWO BATTERY COMPARTMENT CRACKS. THIS REPORT IS MADE BASED ON RESULTS OF THE INVESTIGATION PERFORMED ON 09/23/2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743869 ANIMAS VIBE INSULIN INFUSION PUMP OYC ANIMAS CORPORATION 10840406100235

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR