BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 7059791 · Received November 27, 2017

    Report

    Report Number
    2531779-2017-27039
    Event Type
    Malfunction
    Date Received
    November 27, 2017
    Report Date
    November 3, 2017
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    OYC
    UDI-DI
    10840406100211
    PMA / PMN Number
    P130007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 11/03/2017 WITH THE FOLLOWING FINDINGS:THE BATTERY COMPARTMENT WAS CRACKED. (B)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED THE BATTERY COMPARTMENT WAS CRACKED. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 11/03/2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839146 ANIMAS VIBE INSULIN INFUSION PUMP OYC ANIMAS CORPORATION 10840406100211

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR