BEUDAMED
    FDA Adverse Event Other Summary report: N

    GENETIC SYSTEMS HIV-1/HIV-2 PEPTIDE EIA

    MDR report key: 609503 · Received May 23, 2005

    Report

    Report Number
    3022521-2005-00001
    Event Type
    Other
    Date Received
    May 23, 2005
    Date of Event
    April 12, 2005
    Report Date
    May 20, 2005
    Manufacturer
    BIO-RAD LABORATORIES, INC.
    Product Code
    MZF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 04/2005, AN ORTHO CLINICAL DIAGNOSTICS REP CALLED & FAXED TO THE BIO-RAD LABORATORIES' TECH SUPPORT DEPARTMENT A COMPLAINT THEY RECEIVED IN 04/2005 REGARDING A GENETIC SYSTEMS HIV-1/HIV-2 PEPTIDE EIA LOT 341XP1-50. THE FAX INDICATED HEARTLAND BLOOD CENTERS IN AURORA, IL REPORTED THAT THEIR LAB RECEIVED A SAMPLE (ID FG44894) AND TESTED IT IN 04/2005 WITH THE FOLLOWING RESULTS: GENETIC SYSTEMS HIV-1/HIV-2 PEPTIDE EIA (LOT - 341XP1-50) WAS NON-REACTIVE, WITH SIGNAL TO CUT OFF RATIO=0.73 (>OR = TO 1.0 IS REACTIVE). CHIRON NAT WAS INITIALLY REACTIVE IN A BLOOD DONOR POOL OF 16 SAMPLES. ADDITIONAL TESTING OF THE INDIVIDUAL SAMPLES WITHIN THE POOL INDICATED THAT THE DONOR SAMPLE WAS REACTIVE. BASED ON THE REACTIVE NAT RESULT, NO BLOOD COMPONENTS WERE RELEASED. ABBOTT HIVI - 2 EIA TESTING WAS REPEAT REACTIVE WITH ODS APPROXIMATELY TWICE THE CUT OFF. IN 04/2005, THE GENETIC SYSTEMS HIV-1 WESTERN BLOT CONFIRMATORY TEST WAS INDETERMINATE. ORTHO ALSO STATED ON 04/2005, THE DONOR WAS REDRAWN ON 04/2005 ( EIGHT DAYS LATER) AND THE SAMPLE (ID LW35757) WAS RUN ON THE GENETIC SYSTEMS HIV-1/HIV-2 PEPTIDE EIA IN TRIPLICATE. THIS SECOND SAMPLE WAS REPEATEDLY REACTIVE WITH ODS GRETER THAN 2.2

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENETIC SYSTEMS HIV-1/HIV-2 PEPTIDE EIA IVD, EIA MZF BIO-RAD LABORATORIES, INC. NA 341XP1-50

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN