BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOPLEX 2200

    MDR report key: 23351235 · Received October 21, 2025

    Report

    Report Number
    2915274-2025-00001
    Event Type
    Malfunction
    Date Received
    October 21, 2025
    Date of Event
    October 8, 2025
    Report Date
    October 21, 2025
    Manufacturer
    BIO-RAD LABORATORIES, INC
    Product Code
    NSU
    UDI-DI
    00847865002813
    PMA / PMN Number
    BK140112
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A CUSTOMER REPORTED BEING SPRAYED IN THE FACE WITH LIQUID FROM THE BIOPLEX 2200 INTERNAL WASTE OVERFLOW CONTAINER AFTER MANUALLY EMPTYING IT DURING ERROR 13211 (GENERAL PURPOSE WASTE - UNABLE TO PURGE). THE CUSTOMER CLARIFIED THAT THE LIQUID CONTACTED ONLY HER FACE AND DID NOT REACH THE EYES. SHE PERFORMED IMMEDIATE DECONTAMINATION OF FACE AND EYES USING THE EYEWASH STATION. NO SYMPTOMS OR IRRITATION WERE REPORTED FOLLOWING THE INCIDENT. ACCORDING TO THE USER MANUAL, THE INTERNAL WASTE OVERFLOW CONTAINER COLLECTS OVERFLOW FROM THE GENERAL-PURPOSE WASTE AND SHEATH FLUID RESERVOIRS, MEANING THE LIQUID LIKELY CONSISTED MAINLY OF SHEATH AND CLEANING FLUIDS FROM CLEAN STATIONS WITH A SMALL POSSIBLE AMOUNT OF GENERAL-PURPOSE WASTE CONTAINING TRACE PATIENT SAMPLE RESIDUE. AS STATED IN SECTION 2.3.6.2 OF THE OPERATION MANUAL, THE INTERNAL OVERFLOW CONTAINER IS A BACKUP RESERVOIR INTENDED TO CAPTURE OVERFLOW ONLY UNDER ERROR CONDITIONS FROM THE GENERAL-PURPOSE WASTE OR SHEATH FLUID RESERVOIRS. UNDER NORMAL OPERATION, IT IS NOT EXPECTED TO RECEIVE ANY FLUID, AND IF IT DOES THIS MAY REPRESENT A SERIOUS ERROR CONDITION AND THE ERROR MESSAGE "13211 GENERAL PURPOSE WASTE - UNABLE TO PURGE" INSTRUCTS THE OPERATOR TO CONTACT BIO-RAD TECHNICAL SUPPORT. ADDITIONALLY, ACCORDING TO THE BIOPLEX 2200 OPERATION MANUAL SECTION 11.8, THE INTERNAL OVERFLOW CONTAINER MAY BE EMPTIED AND CLEANED BY THE OPERATOR AS PART OF ON-DEMAND MAINTENANCE AND SHOULD BE PERFORMED AS DESCRIBED IN THE TROUBLESHOOTING SECTION 11.8.4 OR AFTER CONSULTATION WITH BIO-RAD TECHNICAL SUPPORT. THE BIOPLEX 2200 PROCESSES HUMAN SERUM AND PLASMA SAMPLES FOR VARIOUS SEROLOGICAL ASSAYS, THEREFORE, THE GENERAL-PURPOSE WASTE MAY CONTAIN TRACE RESIDUES OF PATIENT MATERIAL TOGETHER WITH DILUTED REAGENTS AND WASH BUFFERS, CLASSIFYING IT AS BIOHAZARDOUS LABORATORY WASTE. WHILE THE LIKELIHOOD OF VIABLE INFECTIOUS PARTICLES IN POST-ASSAY WASTE IS VERY LOW DUE TO DILUTION AND EXPOSURE TO PROTEIN-DENATURING REAGENTS, TRACE CONTAMINATION BY BLOOD-BORNE PATHOGENS CANNOT BE FULLY EXCLUDED. SECTION 1.4.1 "BIOHAZARDS" OF THE OPERATION MANUAL DISPLAYS A BIOHAZARD WARNING, STATING THAT HANDLING AND DISPOSING OF SOLID AND LIQUID WASTE, INCLUDING LIQUID WASTE CONTAINERS, MAY EXPOSE THE OPERATOR TO BIOHAZARDOUS CONDITIONS AND INSTRUCTS USERS TO PROTECT THEMSELVES FROM POTENTIALLY BIOHAZARDOUS MATERIALS WITH ADHERENCE TO THE DESCRIBED GUIDELINES, INCLUDING ALWAYS WEARING LABORATORY GLOVES, COATS, AND SAFETY GLASSES WITH SIDE SHIELDS OR GOGGLES, AND TO COMPLY WITH ANY LOCAL GUIDELINES SPECIFIC TO THEIR LABORATORY AND LOCATION. ADDITIONALLY, SECTION 11.8.4, DESCRIBING THE CLEANING OF THE INTERNAL OVERFLOW CONTAINER, LIKEWISE DISPLAYS A BIOHAZARD WARNING, REINFORCING THAT APPROPRIATE PROTECTIVE WEAR MUST BE USED DURING THIS MAINTENANCE PROCEDURE.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED BEING SPRAYED IN THE FACE WITH LIQUID FROM THE BIOPLEX 2200 INTERNAL WASTE OVERFLOW CONTAINER AFTER MANUALLY EMPTYING IT DURING ERROR 13211 (GENERAL PURPOSE WASTE - UNABLE TO PURGE). CUSTOMER HAS FLUSHED HER FACE AND EYES USING THE EYEWASH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234700 BIOPLEX 2200 Instrumentation for clinical multiplex test systems NSU BIO-RAD LABORATORIES, INC BIOPLEX 2200 00847865002813

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other