BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIDIAN CALAS CRYPTOCOCCAL ANTIGEN LATEX

    MDR report key: 1277356 · Received December 17, 2008

    Report

    Report Number
    MW5009511
    Event Type
    Malfunction
    Date Received
    December 17, 2008
    Date of Event
    November 26, 2008
    Report Date
    December 5, 2008
    Product Code
    GMD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CALAS CRYPTOCOCCAL ANTIGEN LATEX AGGLUTINATION SYSTEM FROM MERIDIAN BIOSCIENCE, INC. THIS KIT LOT NUMBER IS 140108.242. THE PRONASE FROM THIS KIT (LOT # 1408.169) DID NOT PERFORM WITH REPRODUCIBLE ACCURACY. EACH KIT COMES WITH 2 VIALS OF PRONASE FROM THE SAME LOT. ONE VIAL FROM THIS KIT RESULTED IN 4 POSITIVE SERUM CRYPTOCOCCAL ANTIGENS FROM 2 DIFFERENT PTS. THE SECOND VIAL FROM THE SAME KIT RESULTED IN 4 NEGATIVE SERUM CRYPTOCOCCAL ANTIGENS FROM THE SAME 2 PTS USING SAME SERUM SAMPLES. THE PRONASE THAT RESULTED IN POSITIVE RESULTS WAS CHECKED FOR POSSIBLE CONTAMINATION. IN A CONTROLLED EXPERIMENT, THE PRONASE WAS NOT CONTAMINATED WITH POSITIVE PT SAMPLE OR POSITIVE CONTROL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERIDIAN CALAS CRYPTOCOCCAL ANTIGEN LATEX AGGLUTINATION SYSTEM GMD 140108.242

    Patients

    Seq Age Sex Outcome Treatment
    1