BEUDAMED
    FDA Adverse Event Summary report: N

    MULTISPOT HIV-1/HIV-2 RAPID TEST KIT

    MDR report key: 4173777 · Received October 9, 2014

    Report

    Report Number
    3022521-2014-00005
    Date Received
    October 9, 2014
    Date of Event
    August 26, 2014
    Report Date
    October 7, 2014
    Manufacturer
    BIO-RAD LABORATORIES
    Product Code
    MZF
    PMA / PMN Number
    BP040046
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2014, A CUSTOMER CONTACTED BIO-RAD LABORATORIES TECHNICAL SUPPORT DEPARTMENT CONCERNING A (B)(6) RESULT OBTAINED WITH THE BIO-RAD LABORATORIES' MULTISPOT HIV-1/HIV-2 RAPID TEST KIT. THE PT DID NOT HAVE A PRENATAL SCREEN PERFORMED FOR (B)(4). THE TEST WAS REPEATED AND GAVE A (B)(6) RESULT UPON REPEAT. A FOURTH GENERATION TEST WAS PERFORMED ON THIS SAMPLE AND THE RESULT OBTAINED WAS (B)(6). THE SAMPLE WAS SENT OUT FOR (B)(6) TESTING AND THE (B)(6). THE SAMPLE WAS RETURNED TO BIO-RAD AND PRODUCT SUPPORT TESTING OBTAINED A (B)(6) RESULT ON THE SAME LOT AND ANOTHER LOT BUT OBTAINED A (B)(6)RESULT ON WESTERN BLOT TEST. THE PT WAS TREATED BASED ON THE (B)(6) OBTAINED WITH THE MULTISPOT HIV-1/HIV-2 RAPID TEST KIT. CUSTOMER WAS INFORMED OF TESTING PERFORMED AT BIO-RAD AND WAS ALSO DIRECTED TO PACKAGE INSERT SPECIFIC INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636999 MULTISPOT HIV-1/HIV-2 RAPID TEST KIT IVD, EIA MZF BIO-RAD LABORATORIES 11129900

    Patients

    Seq Age Sex Outcome Treatment
    1