BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GS HIV-1/HIV-2 PLUS O EIA

    MDR report key: 1061898 · Received June 16, 2008

    Report

    Report Number
    3022521-2008-00002
    Event Type
    Malfunction
    Date Received
    June 16, 2008
    Date of Event
    May 19, 2008
    Report Date
    June 16, 2008
    Manufacturer
    BIO-RAD LABORATORIES
    Product Code
    MZF
    PMA / PMN Number
    BL125030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF BIO-RAD PRODUCT SUPPORT LABORATORY TESTING ARE AS FOLLOWS: MULTISPOT RAPID TEST - THE SAMPLE WAS REACTIVE. GS PLUS O EIA - THE SAMPLE WAS STILL NON-REACTIVE ON TWO DIFFERENT LOTS. GS WESTERN BLOT - THE SAMPLE WAS POSITIVE WITH BANDS AT GP160 (1+), P65 (2+) AND P24 (2+). GS RLAV EIA - SAMPLE WAS TESTED IN DUPLICATE WITH REACTIVE RESULTS (S/CO = 3.2, 3.6). IN ADDITION, BIO-RAD TESTED THIS LATER SAMPLE ON THE CE MARKED GENSCREEN ULTRA AG/AB, A 4TH GENERATION EIA TEST AVAILABLE IN OTHER COUNTRY, WHICH WAS REACTIVE (S/CO = 2.4). THIS TEST DETECTS P24 ANTIGEN AND ANTIBODIES. BIO-RAD LABORATORIES TECHNICAL SUPPORT HAS REQUESTED THAT ANOTHER DRAW BE COLLECTED FROM THE PATIENT. THE CUSTOMER REPORTS THAT THE PATIENT IS SCHEDULED TO RETURN IN 2008, AND THEY HAVE REQUESTED A SAMPLE BE DRAWN TO SEND TO BIO-RAD LABORATORIES PRODUCT SUPPORT FOR FURTHER INVESTIGATIONAL TESTING. THIS APPEARS TO BE AN INFECTED INDIVIDUAL WHO HAS NON-REACTIVE GS PLUS O EIA TEST RESULTS BASED ON TWO SEPARATE SAMPLES TESTED ON MULTIPLE LOTS AND IN DIFFERENT LABORATORIES. OTHER TEST KITS APPEAR TO DETECT VIRAL RNA, P24 ANTIGEN AND WEAK ANTIBODIES, SUGGESTING EARLY SEROCONVERSION. IF THERE IS ADDITIONAL INFORMATION OBTAINED AFTER BIO-RAD LABORATORIES PRODUCT SUPPORT COMPLETES THE TESTING ON THE NEW DRAW, MEDWATCH FORM FDA 3500A WILL BE UPDATED AND SUBMITTED. THE CUSTOMER REPORTS THAT THE PATIENT HAS STARTED ANTI-VIRAL THERAPY.

    Description of Event or Problem · 1

    IN 2008 BIO-RAD LABORATORIES TECHNICAL SUPPORT RECEIVED A CUSTOMER COMPLAINT FROM THE MEDICAL CENTER. THE CUSTOMER STATED THAT THEY HAD RECEIVED A SERUM SAMPLE FROM ANOTHER LABORATORY WHO HAD REQUESTED A WESTERN BLOT TEST ON THE SAMPLE DUE TO A LOW POSITIVE RESULT ON AN AUTOMATED ASSAY. THE CUSTOMER STATED THAT PART OF THEIR LABORATORY PROCEDURE IS TO PERFORM ANOTHER SCREENING TEST PRIOR TO PERFORMING WESTERN BLOT TESTING. THEREFORE, THE CUSTOMER PERFORMED THE INITIAL SCREENING IN DUPLICATE ON THE PREVIOUS MONTH, USING THE BIO-RAD GS PLUS O EIA (LOT 278BBB-05) AND OBTAINED THE RESULT OF NON-REACTIVE, WITH SIGNAL TO CUT-OFF (S/CO) VALUES OF (0.4, 0.4). THE CUSTOMER STATED THAT THE SERUM SAMPLE WAS THEN RETESTED IN DUPLICATE ON FOUR DAYS LATER. THE RESULT AGAIN WAS NON-REACTIVE (S/CO = 0.4, 0.5). WESTERN BLOT TESTING WAS THEN PERFORMED USING THE BIO-RAD GS WESTERN BLOT ASSAY. THE CUSTOMER REPORTED A POSITIVE RESULT WITH BANDS AT GP160, P65 AND A DIFFUSE BAND AT P24. THE CUSTOMER REQUESTED THAT THE LABORATORY THAT HAD SENT THE INITIAL SAMPLE REDRAW ANOTHER SAMPLE FROM THE PATIENT. THE REDRAWN SAMPLE WAS TESTED IN DUPLICATE ON FOUR DAYS PRIOR TO ORIGINAL DATE, WITH THE BIO-RAD RAD GS PLUS O EIA (LOT 348BBB-05) AND THE RESULT WAS NON-REACTIVE (S/CO = 0.2, 0.2). THE CUSTOMER ALSO REPORTED THAT THEY HAD PERFORMED TESTING USING THE ABBOTT DIAGNOSTICS ORAQUICK ADVANCE RAPID HIV-1/2 ANTIBODY TEST WITH THE RESULT BEING NEGATIVE. THE CUSTOMER STATED THAT THE REDRAWN SAMPLE HAD BEEN SENT OUT FOR VIRAL LOAD TESTING. THE HIV-1 VIRAL LOAD VALUE WAS >500,000 RNA COPIES/ML. THE PATIENT DENIES PARTICIPATING IN AN HIV VACCINE TRIAL AND DENIES TRAVEL TO AFRICA OR OUTSIDE THE U.S. BIO-RAD LABORATORIES TECHNICAL SUPPORT REQUESTED THAT THE CUSTOMER SEND THE PT SERUM SAMPLE TO THE BIO-RAD PRODUCT SUPPORT LABORATORY FOR INVESTIGATIONAL TESTING. BIO-RAD LABORATORIES PRODUCT SUPPORT LABORATORY TESTED THE SAMPLE ON THE BIO-RAD MULTISPOT RAPID TEST (LOT 950988), THE BIO-RAD GS PLUS O EIA (LOT 091CBB), THE BIO-RAD GS WESTERN BLOT (LOT 950789) AND THE BIO-RAD GS RLAV EIA (LOT 008CCAA).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GS HIV-1/HIV-2 PLUS O EIA IVD, EIA MZF BIO-RAD LABORATORIES 278BBB-05

    Patients

    Seq Age Sex Outcome Treatment
    1