BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 553467 · Received August 26, 2004

    Report

    Report Number
    MW1033093
    Event Type
    Malfunction
    Date Received
    August 26, 2004
    Date of Event
    April 1, 2004
    Report Date
    August 25, 2004
    Manufacturer
    *
    Product Code
    MHJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    BD COLORPAK TEST FOR CRYPTOSPORIDIUM AND GIARDIA DETECTION IN STOOL HAD A 85% FALSE-POSITIVE RATE. IN YEAR 2004 701 TESTS ON STOOL WERE PERFORMED: 13 WERE POSITIVE BY COLORPAK FOR CRYPTOSPORIDIUM BUT ONLY 2 COULD BE CONFIRMED BY EITHER MICROSCOPIC EXAM OR IMMUNOFLUORESCENT MICROSCOPY. THERE WERE FALSE-POSITIVE TESTS FOR FOUR STRAIGH MONTHS. ALL 10 TESTS POSITIVE FOR GIARDIA BY COLORPAK WERE CONFIRMED EITHER BY MICROSCOPY OR INNUNOFLUORESCENT MICROSCOPY. DURING APPROX THE SAME PERIOD, A DIFFERENT RAPID TEST -REMEL- CORRECTLY DETECTED ONLY THE TRUE-POSITIVES AND NONE OF THE FALSE-POSITIVES. CONFIRMATORY TESTING OF ALL POSITIVES WAS INSTITUTED AFTER THE LAST RECALL OF THIS PRODUCT LAST WINTER. LOT NUMBER 0712260 WAS IN USE. LOT NUMBER 071299 WAS IN USE. AND 071318 WAS PLACED IN USE LOT 071318 APPEARS NOT TO CAUSE FALSE-POSITIVES ALTHOUGH THE OBSERVATION PERIOD IS STILL SHORT, ALTHOUGH IT IS POSSIBLE THAT SOME OF THE FALSE POSITIVES WERE ALSO CAUSED BY USE OF THIS LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * * MHJ * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other