BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENETIC SYSTEMS HIV-1/HIV-2 PLUS O EIA

    MDR report key: 9187846 · Received October 14, 2019

    Report

    Report Number
    3022521-2019-00002
    Event Type
    Injury
    Date Received
    October 14, 2019
    Date of Event
    August 2, 2019
    Report Date
    October 14, 2019
    Manufacturer
    BIO-RAD LABORATORIES
    Product Code
    MZF
    UDI-DI
    00847865001953
    PMA / PMN Number
    BL125030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ON SEPTEMBER 19, 2019 BIO-RAD TECHNICAL SUPPORT RECEIVED A COMPLAINT FORWARDED FROM A DISTRIBUTION PARTNER ABOUT AN INCIDENT THAT HAPPENED AT CUSTOMER FACILITY. THE INITIAL COMPLAINT WAS FOR AN INCREASE IN INITIALLY REACTIVE (IR) RESULTS THAT DID NOT REPEAT IN SECONDARY TESTING USING THE BIO-RAD GS HIV-1/HIV-2 PLUS O ASSAY. AFTER A PRELIMINARY INVESTIGATION IT WAS FOUND THAT THE IR RESULTS IN QUESTION ALL CAME FROM ONE PLATE RUN ON (B)(6) 2019. FURTHER INVESTIGATION INTO THE ISSUE REVEALED THAT THE RESULTS IN QUESTION WERE DONOR SAMPLES THAT WERE, DUE TO USER ERROR, INADVERTENTLY RUN IN NULL STRIPS IN ROWS 9-12 ON THE TEST PLATE. THE CUSTOMER'S PRACTICE IS TO USE PREVIOUSLY TESTED STRIPS THAT HAVE BEEN CLEANED AS NULL STRIPS. PREVIOUSLY USED STRIPS ARE MARKED WITH A BLACK LINE ACROSS THE BOTTOM OF THE STRIP TO INDICATE THEM AS NULL. THE PACKAGE INSERT STATES THAT THE OPERATOR SHOULD "TAKE CARE WHEN ASSEMBLING PARTIAL PLATES WITH COATED AND UNCOATED (NULL) STRIPS, AS AUTOMATED SYSTEMS CANNOT DISTINGUISH BETWEEN THE STRIPS AND WILL REPORT RESULTS FOR ALL WELLS THAT ARE ASSIGNED A SAMPLE ID NUMBER (EVEN IF A NULL STRIP IS INADVERTENTLY PLACED WHERE SAMPLE IDS HAVE BEEN ASSIGNED)." IT IS LIKELY THAT WHEN THESE STRIPS WERE READ BY THE PHOTOMETER AT THE END OF THE RUN THE BLACK LINE CAUSED THE ELEVATED OD READING AND THE SUBSEQUENT IR RESULT. OF THE 31 SAMPLES RUN IN NULL STRIPS, 28 WERE IR AND WERE RETESTED. HOWEVER, THERE WERE 3 NON-REACTIVE RESULTS ON STRIP 12 OF THE PLATE THAT WERE NOT RETESTED. THOSE RESULTS WERE ERRONEOUSLY ACCEPTED BY THE USER, AND THE DONOR UNITS WERE RELEASED FROM THE DONOR CENTER FOR USE. ON SEPTEMBER 27, 2019 ADDITIONAL INFORMATION WAS RECEIVED THAT INDICATED THAT ALL THREE OF THE UNITS THAT WERE RELEASED AS HIV NON-REACTIVE HAD BEEN TRANSFUSED. FURTHERMORE, SINCE THE CUSTOMER COULD NOT DETERMINE IF THE SLIGHTLY ELEVATED ODS IN ROW 8 WERE DUE TO THE USE OF A NULL STRIP OR AN ASSAY STRIP FROM THE KIT, THEY DECIDED TO EXPAND THEIR RECALL TO INCLUDE THE 8 SAMPLES RUN IN ROW 8 OF THE TEST PLATE. IN TOTAL, THE CUSTOMER IS RECALLING 11 DONOR UNITS DUE TO USER ERROR FOR IMPROPER HIV TESTING AND WILL SUBMIT A BIOLOGIC PRODUCT DEVIATION REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    982970 GENETIC SYSTEMS HIV-1/HIV-2 PLUS O EIA IVD, EIA MZF BIO-RAD LABORATORIES 102PBB-50 00847865001953

    Patients

    Seq Age Sex Outcome Treatment
    1 Other