BEUDAMED
    FDA Adverse Event Other Summary report: N

    MULTISPOT HIV-1/HIV-2 RAPID TEST

    MDR report key: 1378341 · Received April 10, 2009

    Report

    Report Number
    3022521-2009-00001
    Event Type
    Other
    Date Received
    April 10, 2009
    Date of Event
    January 17, 2009
    Report Date
    March 9, 2009
    Manufacturer
    BIO-RAD LABORATORIES, INC.
    Product Code
    MZF
    PMA / PMN Number
    BP040046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2009, BIO-RAD LABORATORIES TECHNICAL SUPPORT DEPARTMENT WAS CONTACTED BY A CUSTOMER REGARDING A PATIENT SAMPLE TESTED ON THE BIO-RAD MULTISPOT HIV-1/HIV-2 RAPID TEST KIT. THE CUSTOMER REPORTED THE SAMPLE WAS FROM A (B)(6) INVOLVED IN AN EMPLOYEE EXPOSURE. THE INITIAL TESTING OF THE PATIENT SAMPLE WAS PERFORMED ON (B)(6) 2009, WITH A RESULT OF (B)(6). REPEAT TESTING WAS PERFORMED ON (B)(6) 2009, USING THE ORIGINAL PATIENT SAMPLE AND A REDRAWN SAMPLE. AGAIN TESTING WAS PERFORMED USING THE MULTISPOT HIV-1/HIV-2 RAPID TEST KIT AND THE RESULTS WERE (B)(6). THE PATIENT SAMPLE WAS THEN SENT TO A REFERENCE LABORATORY FOR (B)(6) TESTING WITH THE BIO-RAD GS HIV-1/HIV-2 PLUS (B)(6) TEST KIT. THE (B)(6) RESULT WAS REPORTED AS (B)(6). A (B)(6) WAS ALSO ORDERED ON THE (B)(6) PATIENT AND WAS REPORTED AS NORMAL. ON (B)(6) 2009, THE CUSTOMER NOTIFIED BIO-RAD LABORATORIES TECHNICAL SUPPORT DEPARTMENT THAT DUE TO THE ORIGINAL MULTISPOT HIV-1/HIV-2 RAPID TEST (B)(6) RESULT ON (B)(6) 2009, THE EMPLOYEE BEGAN (B)(6). THE EMPLOYEE DISCONTINUED THE (B)(6) THERAPY ON (B)(6) 2009, SINCE RECEIVING THE (B)(6) TEST RESULT OF (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTISPOT HIV-1/HIV-2 RAPID TEST IVD MZF BIO-RAD LABORATORIES, INC. 955994

    Patients

    Seq Age Sex Outcome Treatment
    1