BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® MPX - 480T

    MDR report key: 23169449 · Received September 29, 2025

    Report

    Report Number
    2243471-2025-03964
    Event Type
    Malfunction
    Date Received
    September 29, 2025
    Date of Event
    April 29, 2024
    Report Date
    September 29, 2025
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG
    Product Code
    QHO
    PMA / PMN Number
    BL125576
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    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 (LOT K00715) PERFORMED WITHIN SPECIFICATIONS. A REVIEW OF THE RUN FILE FOR THE SAMPLE (ID: (B)(6)) CONFIRMED A NON-REACTIVE HCV RESULT, WITH ALL TARGETS NEGATIVE AND THE INTERNAL CONTROL VALID. ADDITIONALLY, THE PCR GROWTH CURVES FOR THE INTERNAL CONTROL AND POSITIVE CONTROLS WERE ROBUST AND SIGMOIDAL, INDICATING PROPER TARGET RECOVERY, AMPLIFICATION, AND DETECTION. THE OBSERVED DISCREPANCY BETWEEN THE COBAS MPX ASSAY AND THE SEROLOGY TESTS IS CONSISTENT WITH DIFFERENCES IN THE DETECTION METHODS OF THE TWO ASSAYS. THE COBAS MPX ASSAY DETECTS VIRAL RNA, WHILE SEROLOGY TESTS DETECT ANTIBODIES, WHICH CAN PERSIST AFTER A RESOLVED INFECTION OR DURING SUCCESSFUL ANTIVIRAL TREATMENT. GIVEN THE PATIENT'S HISTORY OF HCV INFECTION, THE RESULTS ARE CONSISTENT WITH A RESOLVED INFECTION OR SUPPRESSED VIRAL LOAD DUE TO TREATMENT. NO QUALITY CONTROL ISSUES RELATED TO THE CUSTOMER ALLEGATION WERE IDENTIFIED. BASED ON THE AVAILABLE INFORMATION, THE MOST LIKELY EXPLANATION FOR THE DISCREPANT RESULTS IS A RESOLVED HCV INFECTION. THE DEVICE REMAINS IN OPERATION AT THE CUSTOMER SITE.

    Description of Event or Problem · 0

    THE INITIAL REPORTER ALLEGED DISCREPANT HEPATITIS C VIRUS (HCV) RESULTS FOR A SAMPLE TESTED USING THE KIT COBAS 58/68/8800 MPX 480T IVD ASSAY ON THE COBAS 6800 INSTRUMENT. THE SAMPLE WAS TESTED USING THE COBAS MPX ASSAY (POLYMERASE CHAIN REACTION [PCR]) AND GENERATED A NON-REACTIVE RESULT FOR HCV, WITH ALL TARGETS NEGATIVE AND THE INTERNAL CONTROL VALID. THE SAME SAMPLE WAS TESTED THREE TIMES USING SEROLOGY TESTS ON THE ALINITY SYSTEM, WITH ALL THREE TESTS YIELDING POSITIVE RESULTS. THE DISCREPANCY INVOLVES THE COBAS MPX ASSAY DETECTING NO HCV RNA, WHILE THE SEROLOGY TESTS DETECTED HCV ANTIBODIES. NO ADDITIONAL CONFIRMATORY TESTING OR FOLLOW-UP RESULTS WERE PROVIDED IN THE CASE SUMMARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1944986 COBAS® MPX - 480T ASSAY, HYB AND/OR NUCLEIC ACID AMP FOR DETECTION OF HCV RNA, HIV RNA QHO ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG K00715

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown