BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® MPX - 96T

    MDR report key: 23155343 · Received September 26, 2025

    Report

    Report Number
    2243471-2025-03765
    Event Type
    Malfunction
    Date Received
    September 26, 2025
    Date of Event
    June 28, 2024
    Report Date
    September 26, 2025
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG
    Product Code
    QHO
    PMA / PMN Number
    BL125576
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ANALYSIS WAS PERFORMED ON A COBAS 6800 INSTRUMENT (SERIAL NUMBER: (B)(6). THE INVESTIGATION DETERMINED THAT THE COBAS MPX ASSAY PERFORMED WITHIN SPECIFICATIONS, AND NO PRODUCT ISSUE WAS IDENTIFIED. THE DISCREPANT RESULTS OBSERVED DURING TESTING WERE ATTRIBUTED TO A VERY LOW VIRAL LOAD NEAR OR BELOW THE ASSAY'S LIMIT OF DETECTION (LOD). THIS VARIABILITY IN RESULTS IS CONSISTENT WITH THE EXPECTED PERFORMANCE OF THE ASSAY, WHICH STATES THAT LOWER CONCENTRATIONS OF HBV DNA CORRESPOND TO REDUCED REACTIVITY RATES. ADDITIONALLY, THE SEROLOGICAL FINDINGS, INCLUDING POSITIVE RESULTS FOR HBSAG AND ANTI-HBC, WERE CONSISTENT WITH PRIOR EXPOSURE TO HBV AND DO NOT INDICATE ACTIVE VIRAL REPLICATION. A REVIEW OF QUALITY CONTROL DATA CONFIRMED THAT ALL RESULTS WERE WITHIN EXPECTED RANGES, AND NO ISSUES RELATED TO THE IMPLICATED LOT: (K20768) OR SOFTWARE ANOMALIES WERE IDENTIFIED. THE DEVICE REMAINS IN OPERATION AT THE CUSTOMER SITE.

    Description of Event or Problem · 0

    THE INITIAL REPORTER ALLEGED A POTENTIAL FALSE NON-REACTIVE HEPATITIS B VIRUS (HBV) RESULT USING THE KIT COBAS 6800/8800 MPX 96T CE-IVD ASSAY ON THE COBAS 6800 INSTRUMENT. ON (B)(6) 2024, A PCR POOL (ID: (B)(6) TESTED POSITIVE FOR HBV USING THE COBAS MPX ASSAY. SUBSEQUENT POOL RESOLUTION TESTING ON THE SAME DAY DID NOT IDENTIFY ANY HBV-REACTIVE SAMPLES. ADDITIONAL SEROLOGICAL TESTING OF SAMPLE (B)(6) REVEALED POSITIVE RESULTS FOR HEPATITIS B SURFACE ANTIGEN (HBSAG) AND ANTI-HEPATITIS B CORE ANTIBODY (ANTI-HBC). ON (B)(6) 2024, REPEAT TESTING OF SAMPLE (B)(6) USING THE COBAS MPX ASSAY YIELDED A POSITIVE RESULT FOR HBV. A 1:16 DILUTION OF THE SAME SAMPLE TESTED NEGATIVE FOR HBV. NO ALLEGATIONS OF HARM WERE ASSOCIATED WITH THE DISCREPANT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2059224 COBAS® MPX - 96T ASSAY, HYB AND/OR NUCLEIC ACID AMP FOR DETECTION OF HCV RNA, HIV RNA QHO ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG K20768

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown