BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOPLEX 2200 ANTI-CCP REAGENT PACK

    MDR report key: 16422988 · Received February 22, 2023

    Report

    Report Number
    1000135116-2023-00001
    Event Type
    Malfunction
    Date Received
    February 22, 2023
    Manufacturer
    BIO-RAD LABORATORIES,INC
    Product Code
    NHX
    UDI-DI
    00847865000857
    PMA / PMN Number
    K093954
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BIO-RAD LABORATORIES HAS RECEIVED REPORTS OF DISCREPANT RESULTS WITH LOT NO. 301481 FROM FOUR CUSTOMERS PERFORMING LOT-TO-LOT VALIDATION AGAINST PREVIOUS LOTS. INTERNAL TESTING AT BIO-RAD HAS DEMONSTRATED THAT LOT NO. 301481 EXHIBITS A REDUCTION IN SPECIFICITY. THE BIAS WAS OBSERVED ON THE LOW END OF THE ASSAY RANGE AND NONE OF THE FALSE POSITIVE RESULTS OBSERVED EXCEEDED 9 U/ML (3X CUT-OFF). THIS REDUCTION IN SPECIFICITY MAY LEAD TO AN INCREASE IN THE NUMBER OF FALSE POSITIVES AND COULD LEAD TO INCORRECT DIAGNOSIS OF RHEUMATOID ARTHRITIS AND UNNECESSARY MEDICAL TREATMENT.

    Description of Event or Problem · 0

    BIO-RAD LABORATORIES HAS RECEIVED REPORTS OF DISCREPANT RESULTS WITH LOT NO. 301481 FROM FOUR CUSTOMERS PERFORMING LOT-TO-LOT VALIDATION AGAINST PREVIOUS LOTS. INTERNAL TESTING AT BIO-RAD HAS DEMONSTRATED THAT LOT NO. 301481 EXHIBITS A REDUCTION IN SPECIFICITY (POTENTIAL FOR FALSE POSITIVE RESULTS). THERE WERE NO REPORTED ADVERSE EVENT WITH THIS LOT. HOWEVER,FALSE POSITIVE ANTI-CCP RESULTS COULD LEAD TO INCORRECT DIAGNOSIS OF RHEUMATOID ARTHRITIS AND UNNECESSARY MEDICAL TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115816 BIOPLEX 2200 ANTI-CCP REAGENT PACK BIOPLEX 2200 ANTI-CCP NHX BIO-RAD LABORATORIES,INC BIOPLEX 2200 ANTI-CCP REAGENT PACK 301481 00847865000857

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown