BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® MPX - 480T

    MDR report key: 23135908 · Received September 24, 2025

    Report

    Report Number
    2243471-2025-03603
    Event Type
    Malfunction
    Date Received
    September 24, 2025
    Date of Event
    June 17, 2024
    Report Date
    September 24, 2025
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG
    Product Code
    QHO
    PMA / PMN Number
    BL125576
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    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 COBAS MPX ASSAY PERFORMED WITHIN SPECIFICATIONS. THE POSITIVE CONTROL FOR HBV WAS ROBUST AND EXHIBITED A SIGMOIDAL AMPLIFICATION CURVE, INDICATING PROPER ASSAY FUNCTIONALITY. THE DATA ANALYSIS REVEALED LATE AMPLIFICATION FOR THE RESULTS FROM 03-JUN-2024 AND 17-JUN-2024, WITH CYCLE THRESHOLD (CT) VALUES OF 38.4 AND 36.8, RESPECTIVELY. THESE FINDINGS ARE CONSISTENT WITH THE ASSAY'S LIMIT OF DETECTION (LOD), WHERE REACTIVE AND NON-REACTIVE RESULTS MAY OCCUR AND ARE EXPECTED UNDER CERTAIN CONDITIONS. THE ROOT CAUSE OF THE REPORTED DISCREPANT RESULTS IS MOST LIKELY RELATED TO THE ASSAY'S LOD. IN THE CLINICAL CONTEXT, WITH SEROLOGY CONSISTENTLY REACTIVE, THE DONOR IS LIKELY TO HAVE A CHRONIC HBV INFECTION WITH PERSISTENT HBSAG IN THE BLOOD. A PRODUCT ISSUE WAS NOT IDENTIFIED DURING THE INVESTIGATION.

    Description of Event or Problem · 0

    THE INITIAL REPORTER ALLEGED DISCREPANT RESULTS FOR HEPATITIS B VIRUS (HBV) TESTING USING THE KIT COBAS 6800/8800 MPX 480T CE-IVD ASSAY ON THE COBAS 6800 INSTRUMENT. THE REPORTED RESULTS FOR HBV NUCLEIC ACID TESTING (NAT) WERE AS FOLLOWS: ON (B)(6) 2022, THE SAMPLE WAS INITIALLY REACTIVE, BUT A REPEAT TEST WAS NON-REACTIVE. ON (B)(6) 2022, (B)(6) 2023, AND (B)(6) 2024, THE RESULTS WERE NON-REACTIVE. ON (B)(6) 2023 AND (B)(6) 2024, THE RESULTS WERE REACTIVE. ON (B)(6) 2024, THE SAMPLE WAS INITIALLY REACTIVE, BUT A REPEAT TEST WAS NON-REACTIVE. SEROLOGY TESTING FOR HBV USING AN ABBOTT ASSAY WAS REACTIVE FOR ALL SAMPLES TESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1643056 COBAS® MPX - 480T ASSAY, HYB AND/OR NUCLEIC ACID AMP FOR DETECTION OF HCV RNA, HIV RNA QHO ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG K10507

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown