BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIVIDAS

    MDR report key: 360507 · Received November 12, 2001

    Report

    Report Number
    1950204-2001-00016
    Event Type
    Malfunction
    Date Received
    November 12, 2001
    Date of Event
    October 8, 2001
    Report Date
    November 12, 2001
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    IZT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER WAS RUNNING "QCT" TEST STRIPS ON PUMP AND FAILED THE TEST 4 TIMES. QCR TEST IS A TEST TO DETECT CLOGGED PUMP TUBES. CLOGGED PUMP TUBES COULD RESULT IN FALSE RESULTS BEING REPORTED TO THE PT. THERE ARE NO REPORTS OF FALSE RESULTS BEING GENERATED AT THIS SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50820 MINIVIDAS IMMUNOFLUROMETRIC EQUIPMENT IZT BIOMERIEUX, INC. MINIVIDAS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *