BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® MPX - 96T

    MDR report key: 23158513 · Received September 26, 2025

    Report

    Report Number
    2243471-2025-03872
    Event Type
    Malfunction
    Date Received
    September 26, 2025
    Date of Event
    September 26, 2023
    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
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT OCCURRED ON A COBAS 6800 SYSTEM (SERIAL NUMBER: (B)(6). THE INVESTIGATION DETERMINED THAT THE COBAS MPX ASSAY (LOT J24218) PERFORMED WITHIN SPECIFICATIONS. A REVIEW OF THE PROVIDED DATA, INCLUDING QUALITY CONTROL AND REAL-TIME WORLDWIDE CUSTOMER DATA, DID NOT INDICATE A PRODUCT ISSUE WITH THE COMPLAINT LOT. ADDITIONALLY, NO HARDWARE ISSUES OR ALGORITHM ANOMALIES WERE IDENTIFIED. THE PCR GROWTH CURVES FOR THE SAMPLES IN QUESTION WERE CORRECTLY CALLED AS POSITIVE BASED ON ALGORITHM PARAMETERS. HOWEVER, THE HBV PCR CURVES FOR THE SAMPLES DID NOT EXHIBIT A ROBUST SIGMOIDAL SHAPE. THE INTERNAL CONTROL (IC) GROWTH CURVES WERE ROBUST AND COMPARABLE TO OTHER SAMPLES AND CONTROLS IN THE RUN, INDICATING THAT THE PCR AND SAMPLE PREPARATION PROCESSES FUNCTIONED AS INTENDED. THE POSITIVE AND NEGATIVE CONTROLS ALSO SHOWED STRONG AMPLIFICATION CURVES, FURTHER SUPPORTING PROPER ASSAY PERFORMANCE. THE UNEXPECTED HBV REACTIVE RESULTS FOR THE SAMPLES COULD POTENTIALLY BE ATTRIBUTED TO AN OCCULT HBV INFECTION (OBI), WHICH IS ASSOCIATED WITH VERY LOW VIRAL LOADS AND ALIGNS WITH THE LATE CYCLE THRESHOLD (CT) VALUES OBSERVED. ANOTHER POSSIBLE CAUSE THAT CANNOT BE EXCLUDED IS ENVIRONMENTAL HBV CONTAMINATION OF THE SAMPLES, AS HBV DNA IS MORE STABLE THAN RNA AND MAY FACILITATE CONTAMINATION IN A LABORATORY SETTING. THE INVESTIGATION DID NOT IDENTIFY ANY PRODUCT-RELATED ISSUES CONTRIBUTING TO THE REPORTED EVENT.

    Description of Event or Problem · 0

    THE INITIAL REPORTER ALLEGED UNEXPECTED HEPATITIS B VIRUS (HBV) REACTIVE RESULTS FOR TWO DONOR SAMPLES TESTED WITH THE KIT COBAS 6800/8800 MPX 96T CE-IVD ASSAY ON THE COBAS 6800 SYSTEM. THE FIRST SAMPLE (ID (B)(6) WAS TESTED ON (B)(6) 2023 AND GENERATED AN HBV REACTIVE RESULT WITH A CYCLE THRESHOLD (CT) VALUE OF 40.01 AND AN INTERNAL CONTROL (IC) CT VALUE OF 36.9. THE SECOND SAMPLE (ID (B)(6) WAS TESTED ON (B)(6) 2023 AND GENERATED AN HBV REACTIVE RESULT WITH A CT VALUE OF 38.68 AND AN IC CT VALUE OF 36.8. THE CUSTOMER NOTED THAT THE TWO DONORS ASSOCIATED WITH THE UNEXPECTED HBV REACTIVE RESULTS HAD NO HISTORY OF HEPATITIS B SURFACE ANTIGEN IN SEROLOGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310643 COBAS® MPX - 96T ASSAY, HYB AND/OR NUCLEIC ACID AMP FOR DETECTION OF HCV RNA, HIV RNA QHO ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG J24218

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown