BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® MPX - 480T

    MDR report key: 23155974 · Received September 26, 2025

    Report

    Report Number
    2243471-2025-03778
    Event Type
    Malfunction
    Date Received
    September 26, 2025
    Date of Event
    August 29, 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
    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. THE RMC POSITIVE AND NEGATIVE CONTROLS EXHIBITED ROBUST AMPLIFICATION CURVES, CONFIRMING PROPER PCR AND SAMPLE PREPARATION PROCESSES. ADDITIONALLY, THE INTERNAL CONTROL FOR SAMPLE ID (B)(6) DEMONSTRATED A ROBUST AMPLIFICATION CURVE, INDICATING THE ABSENCE OF POTENTIAL PCR INHIBITORS IN THE SAMPLE MATRIX. THE MOST PLAUSIBLE EXPLANATION FOR THE NON-REACTIVE NAT RESULT OF SAMPLE ID (B)(6) IS AN HIV SAMPLE WITH A VIRAL LOAD POTENTIALLY BELOW THE LIMIT OF DETECTION (LOD) OF THE COBAS MPX ASSAY. ALTERNATIVELY, THE POSSIBILITY OF A FALSE POSITIVE SEROLOGY RESULT CANNOT BE EXCLUDED BASED ON THE AVAILABLE DATA. NO HARM WAS CAUSED OR ALLEGED, AND THE DEVICE REMAINS IN OPERATION AT THE CUSTOMER SITE.

    Description of Event or Problem · 0

    THE INITIAL REPORTER ALLEGED A POTENTIAL FALSE NEGATIVE RESULT FOR HIV-1 USING THE KIT COBAS 58/68/8800 MPX 480T IVD ASSAY ON THE COBAS 6800 INSTRUMENT. THE ALLEGATION INVOLVED A SAMPLE (ID: (B)(6) THAT YIELDED DISCREPANT RESULTS. THE COBAS HIV-1 DUO TEST DETECTED AN ANTI-HIV REACTIVE RESULT WITH A CUT-OFF INDEX (COI) OF 4.08, WHILE THE COBAS MPX ASSAY PRODUCED A NON-REACTIVE RESULT. THE BLOOD COMPONENT ASSOCIATED WITH THE SAMPLE WAS REJECTED BY THE CUSTOMER, AND NO ADDITIONAL MATERIAL FROM THE ORIGINAL SAMPLE WAS AVAILABLE FOR FURTHER TESTING AS THE COLLECTION TUBE WAS DISCARDED. A NEW SAMPLE WAS REQUESTED FROM THE DONOR FOR CONFIRMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301379 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