BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® MPX - 96T

    MDR report key: 23125175 · Received September 23, 2025

    Report

    Report Number
    2243471-2025-03488
    Event Type
    Malfunction
    Date Received
    September 23, 2025
    Date of Event
    September 6, 2022
    Report Date
    September 23, 2025
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG
    Product Code
    QHO
    PMA / PMN Number
    BL125576
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ANALYSIS WAS PERFORMED ON A COBAS 6800 ANALYZER (SERIAL NUMBER: (B)(6). THE INVESTIGATION DETERMINED THAT THE KIT COBAS 6800/8800 MPX 96T CE-IVD ASSAY PERFORMED WITHIN SPECIFICATIONS. A REVIEW OF THE DATA SHOWED THAT BOTH SAMPLES WERE REACTIVE FOR THE HBV TARGET WITH DELAYED CYCLE THRESHOLD (CT) VALUES DURING THE INITIAL RUN AND LOWER CT VALUES DURING THE RERUN. THE CURVES APPEARED NORMAL, AND NO ISSUES WERE IDENTIFIED IN THE DATASET. OCCULT INFECTION WAS RULED OUT BASED ON NON-REACTIVE RESULTS FOR KEY SEROLOGICAL MARKERS AND SUBSEQUENT TESTING OF FRESH SAMPLES, WHICH YIELDED NON-REACTIVE RESULTS. THE FINDINGS SUGGEST THAT THE LIKELY ROOT CAUSE WAS CONTAMINATION INTRODUCED DURING SAMPLE HANDLING OR PROCESSING, PARTICULARLY DURING THE TRANSFER OF MATERIAL FROM THE PRIMARY TUBE TO SECONDARY TUBES. NO INTERNAL NON-CONFORMANCES RELATED TO THE CUSTOMER ALLEGATION WERE IDENTIFIED. THE DEVICE REMAINS IN OPERATION AT THE CUSTOMER SITE.

    Description of Event or Problem · 0

    THE INITIAL REPORTER ALLEGED DISCREPANT RESULTS WITH THE KIT COBAS 6800/8800 MPX 96T CE-IVD ASSAY ON THE COBAS 6800 INSTRUMENT. THE ALLEGATION INVOLVED TWO MATERNAL BLOOD DONOR SAMPLES THAT WERE REACTIVE FOR HEPATITIS B VIRUS (HBV) USING THE MPX ASSAY. HOWEVER, SEROLOGICAL TESTING FOR BOTH SAMPLES SHOWED NON-REACTIVE RESULTS FOR HEPATITIS B SURFACE ANTIGEN (HBSAG) AND HEPATITIS B CORE ANTIBODY (ANTI-HBC), WITH ANTI-HBS RESULTS GREATER THAN 100 CUT-OFF INDEX (COI). THE CUSTOMER SUBSEQUENTLY TESTED FRESH NEW SAMPLES FROM THE SAME DONORS, WHICH YIELDED NON-REACTIVE RESULTS FOR ALL NUCLEIC ACID TESTING (NAT) TARGETS (HIV, HBV, HCV), NON-REACTIVE HBSAG RESULTS, NON-REACTIVE ANTI-HBC RESULTS, AND ANTI-HBS RESULTS OF 138 COI AND 125 COI, RESPECTIVELY. THE INITIAL NAT TESTING WAS CONDUCTED. DURING THE FIRST RUN (BATCH 16), SAMPLES WERE ALIQUOTED FROM PRIMARY TUBES INTO COBAS OMNI TUBES, AND BOTH SAMPLES WERE REACTIVE FOR HBV WITH DELAYED CYCLE THRESHOLD (CT) VALUES OF 36.4 AND 37.5. A SECOND RUN (BATCH 18) WAS PERFORMED DIRECTLY FROM THE SAME PRIMARY TUBES, AND BOTH SAMPLES WERE AGAIN REACTIVE FOR HBV WITH CT VALUES OF 31 AND 29. THE BLOOD WAS RELEASED AS NON-REACTIVE, AND NO HARM WAS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    942307 COBAS® MPX - 96T ASSAY, HYB AND/OR NUCLEIC ACID AMP FOR DETECTION OF HCV RNA, HIV RNA QHO ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG H21301

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown