BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GS HIV-1/HIV-2 PLUS O EIA

    MDR report key: 1472516 · Received June 10, 2009

    Report

    Report Number
    3022521-2009-00002
    Event Type
    Malfunction
    Date Received
    June 10, 2009
    Date of Event
    January 1, 2009
    Report Date
    April 7, 2009
    Manufacturer
    BIO-RAD LABORATORIES
    Product Code
    MZF
    PMA / PMN Number
    BL125030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS DOCUMENTED IN THE LITERATURE, RESULTS OF (B)(6) HAVE BEEN REPORTED (B)(6) IN PERSONS WITH (B)(6) IN RARE SITUATIONS. INFECTION WITH A HIGHLY (B)(6) COULD BE RESPONSIBLE FOR FAILURE TO DETECT THE ANTIBODY. HOWEVER, RESULTS MAY ALSO BE (B)(6) IN RARE CASES OF (B)(6). THE LATTER CASES MOST LIKELY OCCUR DUE TO VERY HIGH VIRAL LOAD IN THE PT AND ANTIGEN EXCESS, RESULTING IN LOW LEVELS OF DETECTABLE FREE ANTIBODY IN THE SERUM. FURTHER DATA ARE NEEDED TO DETERMINE WHICH EXPLANATION IS MORE LIKELY FOR THE PT DESCRIBED ABOVE. BIO RAD HAS REQUESTED ANOTHER SAMPLE FOR FURTHER INVESTIGATIONAL TESTING. IF THERE IS ADD'L INFO OBTAINED AFTER BIO-RAD LABORATORIES PRODUCT SUPPORT COMPLETES THE TESTING, MEDWATCH FORM FDA 3500A WILL BE UPDATED AND SUBMITTED. THE CUSTOMER REPORTS THAT THE PT IS CURRENTLY UNDERGOING TREATMENT AND THAT THE VIRAL LOAD HAS DROPPED SIGNIFICANTLY.

    Description of Event or Problem · 1

    ON (B)(6) 2009, A CUSTOMER CONTACTED BIO-RAD LABORATORIES TECHNICAL SUPPORT DEPARTMENT WITH A CONCERN REGARDING A (B)(6) PT TEST RESULT FOR (B)(6). THE CUSTOMER REPORTED THAT THE PT IS A (B)(6) FEMALE (B)(6) WHO WAS DIAGNOSED (B)(6) AGO WITH (B)(6). THE CUSTOMER STATED THAT WHEN TESTING THE PT SAMPLE USING (B)(6), LOT NUMBER 324CBB, THE RESULT WAS (B)(6). THE CUSTOMER ALSO TESTED THE PT SAMPLE USING (B)(6), LOT NUMBER 956713, AND THE PT RESULT WAS (B)(6). VIRAL LOAD TESTING WAS ALSO PERFORMED ON THE PT SAMPLE, WITH A RESULT OF (B)(6). BIO-RAD LABORATORIES TECHNICAL SUPPORT REQUESTED THE CUSTOMER SEND A PT SAMPLE TO BIO-RAD PRODUCT SUPPORT LABORATORY FOR INVESTIGATIONAL TESTING. THE PT SAMPLE WAS REC'D BY THE PRODUCT SUPPORT LABORATORY ON (B)(6) 2009. THE RESULTS OF BIO-RAD PRODUCT SUPPORT LABORATORY TESTING OF THE SAMPLE AREA AS FOLLOWS: (B)(6) (LOT 960383) - (B)(6). (B)(6) (LOT 007DBB) - (B)(6). (B)(6) (LOT 960733) - (B)(6). (B)(6) (LOT 040DAA) - (B)(6). IN ADDITION, BIO-RAD TESTED THE SAMPLE ON (B)(6), WHICH WAS ALSO (B)(6), AND ON (B)(6), WHICH WAS (B)(6). THE PT SAMPLE WAS SENT TO AN OUTSIDE LABORATORY (B)(6) BY BIO-RAD FOR FURTHER TESTING USING ANOTHER MFR'S (B)(6). ON (B)(6) 2009, PRODUCT SUPPORT REC'D (B)(6) TEST RESULTS FROM THE (B)(6).

    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 324CBB-05

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR