BEUDAMED
    FDA Adverse Event Other Summary report: N

    MULTISPOT HIV-1/HIV-2 RAPID TEST

    MDR report key: 1006845 · Received February 25, 2008

    Report

    Report Number
    3022521-2008-00001
    Event Type
    Other
    Date Received
    February 25, 2008
    Date of Event
    January 28, 2008
    Report Date
    February 22, 2008
    Manufacturer
    BIO-RAD LABORATORIES
    Product Code
    MZF
    PMA / PMN Number
    BP040046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON 02/01/2008, THE MGR OF RA/QA/CLINICAL AFFAIRS AT BIO-RAD LABORATORIES WAS CONTACTED BY A PHYSICIAN FROM (B) (6) HOSITAL, (B) (6). THE PHYSICIAN STATED THAT WHILE PARTICIPATING IN A SURGERY TO REMOVE A PAROTID TUMOR, THE PHYSICIAN HAD ACCIDENTALLY BEEN STUCK WITH A CONTAMINATED NEEDLE. PER THE HOSPITAL'S IN-HOUSE TESTING PROTOCOL FOR NEEDLE STICK INJURIES A SAMPLE WAS DRAWN FROM THE PT TO TEST FOR THE PRESENCE OF (B) (6) ANTIBODIES. THE INITIAL TEST WAS PERFORMED USING THE BIO-RAD LABORATORIES' MULTISPOT (B) (6) TEST; THE RESULT WAS REACTIVE (IN ONE (B) (6) TEST SPOT ONLY). THE LABORATORY REPEATED THE TESTING AND OBTAINED THE SAME RESULTS. THE PHYSICIAN WAS SUBSEQUENTLY TREATED WITH ANTIVIRAL THERAPY BUT DISCONTINUED THE THERAPY DUE TO FALLING ILL FROM THE TREATMENT. THE PT SAMPLE WAS THEN SENT TO A REFERENCE LAB FOR EIA AND WESTERN BLOT TESTING WITH THE BIO-RAD LABORATORIES GS (B) (6) PLUS O EIA TEST KIT AND THE BIO-RAD LABORATORIES GS (B) (6) WESTERN BLOT KIT. THE EIA RESULTS WERE REPORTED AS NON-REACTIVE AND THE WESTERN BLOT ASSAY WAS INDETERMINATE WITH A +/ - P24 BAND. VIRAL LOAD TEST RESULTS WERE REPORTED AS NEGATIVE WITH >1.7 LOG VIRAL COPIES (>50 COPIES/ML).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTISPOT HIV-1/HIV-2 RAPID TEST IVD MZF BIO-RAD LABORATORIES 947802

    Patients

    Seq Age Sex Outcome Treatment
    1