BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® MPX - 480T

    MDR report key: 23135771 · Received September 24, 2025

    Report

    Report Number
    2243471-2025-03601
    Event Type
    Malfunction
    Date Received
    September 24, 2025
    Date of Event
    October 18, 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 REPORTED EVENT OCCURRED ON A COBAS 6800 ANALYZER (SERIAL NUMBER: (B)(6)). THE INVESTIGATION DETERMINED THAT THERE WAS NO INDICATION OF A PRODUCT-RELATED ISSUE WITH THE COBAS MPX ASSAY (LOT K10507) OR THE COBAS 6800 ANALYZER. DATA ANALYSIS OF SAMPLE ID (B)(6) REVEALED NO ANOMALIES IN THE PCR RAW DATA, ALGORITHM PERFORMANCE, OR AMPLIFICATION CURVES. THE INTERNAL CONTROL AND TARGET AMPLIFICATION CURVES FOR THE POSITIVE AND NEGATIVE CONTROLS WERE ROBUST, INDICATING PROPER FUNCTIONING OF THE PCR AND SAMPLE PREPARATION PROCESSES. ADDITIONALLY, NO HARDWARE ISSUES WERE IDENTIFIED. THE MOST PLAUSIBLE EXPLANATION FOR THE NON-REACTIVE NAT RESULTS IS THAT THE VIRAL LOAD OF THE SAMPLES MAY HAVE BEEN BELOW THE LIMIT OF DETECTION (LOD) OF THE COBAS MPX ASSAY, POTENTIALLY DUE TO THE DONOR'S ENROLLMENT IN AN HIV TREATMENT PROGRAM. THIS ALIGNS WITH THE KNOWN POSSIBILITY OF LOW OR UNDETECTABLE VIRAL LOADS IN INDIVIDUALS UNDERGOING ANTIVIRAL TREATMENT. THE CUSTOMER LATER CONFIRMED THAT NO FURTHER QUESTIONS REMAINED, AND NO ALLEGATIONS OF HARM WERE REPORTED IN THIS CASE.

    Description of Event or Problem · 0

    THE INITIAL REPORTER ALLEGED DISCREPANT HIV RESULTS USING THE KIT COBAS 6800/8800 MPX 480T CE-IVD ASSAY ON THE COBAS 6800 INSTRUMENT. THE COMPLAINT INVOLVES TWO SAMPLES. THE FIRST SAMPLE, TESTED ON (B)(6) 2024, RETURNED A NON-REACTIVE RESULT FOR HIV-1 ON THE COBAS MPX ASSAY. SUBSEQUENT TESTING OF THE SAME SAMPLE USING THE COBAS HIV-1 DUO ASSAY YIELDED REACTIVE RESULTS WITH AN INITIAL CUT-OFF INDEX (COI) OF 586 AND A REPEAT COI OF 709. ADDITIONALLY, AN HIV STRIP TEST PERFORMED ON THE SAME SAMPLE WAS REACTIVE. THE SECOND SAMPLE, TESTED ON (B)(6) 2024, ALSO RETURNED A NON-REACTIVE RESULT FOR HIV-1 ON THE COBAS MPX ASSAY. REPEAT TESTING OF THIS SAMPLE USING THE COBAS HIV-1 DUO ASSAY YIELDED REACTIVE RESULTS WITH AN INITIAL COI OF 18.40 AND A REPEAT COI OF 21.60. THE CUSTOMER EXPRESSED CONCERN ABOUT THE POTENTIAL FOR FALSE NON-REACTIVE RESULTS ON THE COBAS MPX ASSAY FOR HIV-1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2493074 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