BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 6849578 · Received September 7, 2017

    Report

    Report Number
    2531779-2017-20559
    Event Type
    Malfunction
    Date Received
    September 7, 2017
    Report Date
    August 9, 2017
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    OYC
    UDI-DI
    10840406100044
    PMA / PMN Number
    P130007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 8/09/2017 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, THE BATTERY COMPARTMENT WAS FOUND TO BE CRACKED. ADDITIONALLY, THE DISPLAY APPEARED DIM AND DISCOLORED. (B)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A BATTERY COMPARTMENT CRACK AND DIM/FADING DISPLAY. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 8/09/2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630348 ANIMAS VIBE INSULIN INFUSION PUMP OYC ANIMAS CORPORATION 10840406100044

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR