BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS 30 IMMUNOASSAY ANALYZER

    MDR report key: 34172 · Received July 16, 1996

    Report

    Report Number
    MW1009502
    Event Type
    Malfunction
    Date Received
    July 16, 1996
    Report Date
    July 15, 1996
    Manufacturer
    BIOMERIEUX VITEK, INC.
    Product Code
    LJC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    ON 7/5/95, A FIELD REP FROM THE MFR DISCOVERED AN INTERMITTENT PARTIAL OBSTRUCTION OF ONE (1) CHANNEL OF THE INSTRUMENT ASSEMBLY DUE TO A PORTION OF A SOLID PHASE PIPETTE CAP COVER. THIS IS A UNIQUE FAILURE THAT COULD NOT BE DETECTED BY STANDARD QUALITY CONTROL PROCEDURES RECOMMENDED BY THE MFR AND USUALLY PERFORMED BY THE INSTITUTION. THE END RESULT OF THE INSTRUMENT FAILURE WAS SEVENTEEN (17) POSSIBLE FALSE POSITIVE TEST RESULTS FOR CHLAMYDIA TRACHOMATIS COVERING THE TIME PERIOD FROM 5/12/96 TO 7/7/96. APPROPRIATE STEPS ARE BEING TAKEN TO NOTIFY THE PTS AND THEIR PHYSICIANS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIDAS 30 IMMUNOASSAY ANALYZER IMMUNOASSAY ANALYZER LJC BIOMERIEUX VITEK, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO