BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOPLEX 2200 APLS IGM REAGENT PACK

    MDR report key: 16507633 · Received March 8, 2023

    Report

    Report Number
    1000135116-2023-00002
    Event Type
    Malfunction
    Date Received
    March 8, 2023
    Report Date
    March 8, 2023
    Manufacturer
    BIO-RAD LABORATORIES, INC
    Product Code
    MID
    UDI-DI
    00847865000666
    PMA / PMN Number
    K130528
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BIO-RAD LABORATORIES RECEIVED A CUSTOMER COMPLAINT REGARDING INTERMITTENT QC FAILURE WHEN RUNNING BIOPLEX 2200 APLS IGM REAGENT PACKS, LOT NO. 301538. BIO-RAD LABORATORIES DETERMINED THAT A SMALL PERCENTAGE OF THIS REAGENT PACK LOT WAS PACKAGED WITH THE INCORRECT CONJUGATE. THERE WERE NO REPORTED ADVERSE EVENT WITH THIS LOT. HOWEVER, THE USE OF REAGENT PACKS CONTAINING THE INCORRECT CONJUGATE MAY LEAD TO AN INCREASE OF FALSE POSITIVE AND FALSE NEGATIVE RESULTS.

    Description of Event or Problem · 0

    BIO-RAD LABORATORIES RECEIVED A CUSTOMER COMPLAINT REGARDING INTERMITTENT QC FAILURE WHEN RUNNING BIOPLEX 2200 APLS IGM REAGENT PACKS, LOT NO. 301538. BIO-RAD LABORATORIES DETERMINED THAT A SMALL PERCENTAGE OF THIS REAGENT PACK LOT WAS PACKAGED WITH THE INCORRECT CONJUGATE. THERE WERE NO REPORTED ADVERSE EVENT WITH THIS LOT. HOWEVER, THE USE OF REAGENT PACKS CONTAINING THE INCORRECT CONJUGATE MAY LEAD TO AN INCREASE OF FALSE POSITIVE AND FALSE NEGATIVE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715941 BIOPLEX 2200 APLS IGM REAGENT PACK BIOPLEX 2200 APLS IGM MID BIO-RAD LABORATORIES, INC BIOPLEX 2200 APLS IGM REAGENT PACK 301538 00847865000666

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown