BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS

    MDR report key: 319228 · Received March 1, 2001

    Report

    Report Number
    1950204-2001-00001
    Event Type
    Malfunction
    Date Received
    March 1, 2001
    Date of Event
    August 9, 2000
    Report Date
    March 1, 2001
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    JZT
    Removal / Correction Number
    NOT REQUIRED
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    LAB NOTED AFTER RUNNING CONTROLS THAT "RFV'S" FOR SECTION A2 (ONE OF 30 PUMP POSITIONS) WERE MUCH LOWER THAN THE ALLOWED RANGE. FIELD SVC WAS CALLED TO THE SITE AND REPLACED THE PUMP MOTOR ASSEMBLY AT WHICH TIME THE SECTION FUNCTIONED PROPERLY. LAB DETERMINED THAT THE PUMP AT POSITION A2 HAD NOT BEEN PUMPING PROPERLY FOR THE PERIOD OF TIME 8/7/00-8/10/00 DURING WHICH TIME VIDAS ASSAYS HAD BEEN RUN. UPON CORRECTION OF THE PROBLEM THE LAB PERFORMED REPEAT TESTING ON 2 HIV SAMPLES, BOTH OF WHICH GAVE THE SAME RESULTS AS ORIGINALLY REPORTED, 3 HEPATITIS B SAMPLES, TWO OF WHICH GAVE THE SAME RESULTS AS ORIGINALLY REPORTED AND ONE OF WHICH THAT WAS ORIGINALLY REPORTED AS <10 IU RETESTED AT 10-100 IU. THE THREE CHLAMYDIA SAMPLES WERE NOT RETESTED AS THE SAMPLES HAD BEEN DISCARDED. PLEASE NOTE THAT THE HIV AND HEPATITIS B ASSAYS ARE NOT AVAILABLE FOR SALE IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8724 VIDAS IMMUNOFLUOROMETER EQUIPMENT JZT BIOMERIEUX, INC. VIDAS 30 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention