BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BECTON DICKENSON

    MDR report key: 381984 · Received March 11, 2002

    Report

    Report Number
    MW1024390
    Event Type
    Malfunction
    Date Received
    March 11, 2002
    Report Date
    March 11, 2002
    Manufacturer
    *
    Product Code
    MHJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THEY ARE THE DEPT OF PUBLIC HEALTH AND ENVIRONMENT. TWO OF THEIR HOSPS HAVE BEEN USING THE BECTON DICKINSON TEST KITS FOR DETECTING CRYPTOSPORIDIUM AND GIARDIA. THE TEST KITS ARE GIVING FALSE POSITIVE RESULTS FOR BOTH PATHOGENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BECTON DICKENSON CRYPTO/GIARDIA TEST KITS MHJ * * 215934
    2 BECTON DICKENSON CRYPTO/GIARDIA TEST KITS MHJ * * 181165B
    3 BECTON DICKENSON CRYPTO/GIARDIA TEST KITS MHJ * * 181168

    Patients

    Seq Age Sex Outcome Treatment
    1 *