BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 7184914 · Received January 11, 2018

    Report

    Report Number
    2531779-2018-00782
    Event Type
    Malfunction
    Date Received
    January 11, 2018
    Report Date
    December 19, 2017
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    OYC
    PMA / PMN Number
    P130007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON DEC 19, 2018 WITH THE FOLLOWING FINDINGS: THE BATTERY COMPARTMENT WAS CRACKED BELOW THE GRIP PAD TO THE CASE SEAL. (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 DEC 19, 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27910 ANIMAS VIBE INSULIN INFUSION PUMP OYC ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR