BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MUREX WELLCOGEN BACTERIAL ANTIGEN KIT

    MDR report key: 369039 · Received December 20, 2001

    Report

    Report Number
    MW1023689
    Event Type
    Malfunction
    Date Received
    December 20, 2001
    Date of Event
    September 25, 2001
    Report Date
    December 20, 2001
    Manufacturer
    MUREX DIAGNOSTICS DISTRIBUTED BY REMEL, INC.
    Product Code
    GTZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    STATE DEPT OF HEALTH SENT PROFICIENCY TEST SPECIMENS TO LAB HOLDING A STATE LAB PERMIT. A TOTAL OF 84 LABS TESTED A SIMULATED CSF SPECIMEN CONTAINING GROUP B STREPTOCOCCUS USING ANTIGEN DETECTION KITS. EIGHT LABS WERE UNABLE TO DETECT THE PRESENCE OF GROUP B STREP AND ALL OF THESE EIGHT LABS USED THE MUREX WELLCOGEN BACTERIAL ANTIGEN KIT. FIVE OF THE EIGHT USED THE SAME LOT NUMBER. 38 LABS DID DETECT THE PRESENCE OF THIS ANTIGEN USING THE MUREX WELLCOGEN KIT. LOT NUMBER INFO IS UNK. REMEL, THE DISTRIBUTOR OF THIS KIT, HAS BEEN CONTACTED BY RPTR AND BY CLINICAL LABS WHICH USED THE KIT AND OBTAINED AN INCORRECT RESULT. AN INVESTIGATION IS ONGOING. RPTR HAS PROVIDED THEM WITH SAMPLES OF PROFICIENCY TEST SPECIMEN AND THEY HAVE REQUESTED THAT THE KIT BE RETURNED BY AT LEAST ONE CLINICAL LAB SO THAT THEY CAN EVALUATE IT AGAINST RPTR'S SAMPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57734 MUREX WELLCOGEN BACTERIAL ANTIGEN KIT DIRECT ANTIGEN TEST GTZ MUREX DIAGNOSTICS DISTRIBUTED BY REMEL, INC. * KIT: H324310

    Patients

    Seq Age Sex Outcome Treatment
    1 *