BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS

    MDR report key: 319218 · Received March 1, 2001

    Report

    Report Number
    1950204-2001-00002
    Event Type
    Malfunction
    Date Received
    March 1, 2001
    Date of Event
    January 25, 2001
    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

    CUSTOMER REPORTED "WRONG RESULTS" IN POSITION C2 (ONE OF 30 PUMP POSITIONS ON THE INSTRUMENT) IN THAT THE STANDARDS WERE OUTSIDE OF THE RANGE AND MUCH LOWER THAN THE STANDARD RUN ON POSITION C1. IN ADDITION, OCCASIONALLY POSITION C1 WAS LOW AND OUTSIDE OF THE RANGE. THE NEXT MORNING FIELD SERVICE WAS CONTACTED AND WENT TO THE SITE AT WHICH TIME THE PUMP WAS REPLACED AND THE INSTRUMENT WAS PLACED BACK IN SERVICE. CUSTOMER REVIEWED RECORDS AND IDENTIFIED SUSPECT ASSAYS THAT HAD BEEN RUN BETWEEN THE LAST PREVENTATIVE MAINTENANCE ON 12/17/00 AND 1/25/01. IF PT SAMPLES WERE AVAILABLE THEY WERE RETESTED. IF THEY WERE NOT AVAILABLE PTS WERE CONTACTED VIA CONSULTANTS AND GP'S AND ADVISED TO RETURN FOR REPEAT TESTING. THE RESULTS OF THE RETESTS WERE AS FOLLOWS: HIV 20/30 RETESTED. ALL - ORIGINALLY, ALL - ON REPEAT. HEPATITIS B ANTIGEN 10/31 RETESTED. ALL - ORIGINALLY, ALL - ON REPEAT. HEPATITIS B ANTIBODY 13/32 RETESTED, ALL - ORIGINALLY, 10+ ON REPEAT 3 - ON REPEAT. HEPATITIS W/RUBELLA (SCREENING), 27/30, ALL - ORIGINALLY, ALL - ON REPEAT. HEPATITIS B MARKER, 1/6 RETESTED, ALL - ORIGINALLY, ALL - ON RETEST. RUBELLA, 41/64 RETESTED, ALL - ORIGINALLY, 37 + ON RETEST, 4 - ON RETEST. VARICELLA ZOSTER, 0/3 RETESTED. CMV, 1/2 RETESTED, - ORIGINALLY, - ON RETEST. HEPATITIS A, 3/3 RETESTED, ALL - ORIGINALL, ALL - ON RETEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8842 VIDAS IMMUNOFLUOROMETER EQUIPMENT JZT BIOMERIEUX, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention