BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 6863922 · Received September 13, 2017

    Report

    Report Number
    2531779-2017-21160
    Event Type
    Malfunction
    Date Received
    September 13, 2017
    Report Date
    August 21, 2017
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    OYC
    UDI-DI
    10840406100082
    PMA / PMN Number
    P130007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/21/2017 WITH THE FOLLOWING FINDINGS: THE BATTERY COMPARTMENT WAS CRACKED AT THE THREADS ON THE SIDE AND BELOW THE GRIP PAD. (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 08/21/2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643832 ANIMAS VIBE INSULIN INFUSION PUMP OYC ANIMAS CORPORATION 10840406100082

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR