BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® MPX - 96T

    MDR report key: 23089114 · Received September 18, 2025

    Report

    Report Number
    2243471-2025-03152
    Event Type
    Malfunction
    Date Received
    September 18, 2025
    Date of Event
    March 22, 2023
    Report Date
    September 18, 2025
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG
    Product Code
    QHO
    PMA / PMN Number
    BL125576
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 THE COBAS MPX ASSAY PERFORMED WITHIN SPECIFICATIONS. POSITIVE AND NEGATIVE CONTROL RESULTS WERE ROBUST AND SIGMOIDAL, INDICATING PROPER ASSAY FUNCTIONALITY. THE DATA ANALYSIS REVEALED LATE, MINIMAL AMPLIFICATION IN THE INITIAL REACTIVE TEST AND THE FIRST REPEAT TEST, WHICH DID NOT MEET THE CRITERIA FOR A REACTIVE RESULT. THE SECOND REPEAT TEST SHOWED NO LATE, MINIMAL AMPLIFICATION. INTERNAL CONTROL GROWTH CURVES FOR THE SAMPLE INDICATED SOME SUPPRESSION, SUGGESTING A SAMPLE-SPECIFIC CONTRIBUTOR TO THE ASSAY. SEROLOGY TESTING FOR HBV WAS NON-REACTIVE, AND NO ISSUES WERE IDENTIFIED WITH THE REAGENT KIT OR QUALITY CONTROL DATA. A DEFINITIVE ROOT CAUSE FOR THE DISCREPANT RESULTS COULD NOT BE DETERMINED. THE MOST LIKELY EXPLANATION IS ARTIFACT AMPLIFICATION (NON-SPECIFIC AMPLIFICATION) RELATED TO THE SAMPLE QUALITY, AS THE SAMPLE WAS FROM A CADAVERIC DONOR. THE DEVICE REMAINS IN OPERATION AT THE CUSTOMER SITE.

    Description of Event or Problem · 0

    THE INITIAL REPORTER ALLEGED DISCREPANT RESULTS FOR HEPATITIS B VIRUS (HBV) WHEN USING THE KIT COBAS 6800/8800 MPX 96T CE-IVD ASSAY ON THE COBAS 6800 INSTRUMENT. A CADAVERIC DONOR PLASMA SAMPLE WAS TESTED ON (B)(6) 2023 AND GENERATED A REACTIVE RESULT FOR HBV WITH A CYCLE THRESHOLD (CT) VALUE OF 37, SHOWING LATE, MINIMAL AMPLIFICATION. A FIRST REPEAT TEST WAS PERFORMED ON (B)(6) 2023 USING THE SAME SAMPLE TUBE AND WAS NON-REACTIVE, THOUGH IT ALSO SHOWED LATE, MINIMAL AMPLIFICATION THAT DID NOT MEET THE CRITERIA TO BE CALLED REACTIVE. A SECOND REPEAT TEST WAS CONDUCTED ON (B)(6) 2023, AGAIN USING THE SAME SAMPLE TUBE, AND WAS NON-REACTIVE WITHOUT LATE, MINIMAL AMPLIFICATION. SEROLOGY TESTING FOR HBV WAS NON-REACTIVE. THE DONATION, WHICH INVOLVED CORNEAL TISSUE, WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2827139 COBAS® MPX - 96T ASSAY, HYB AND/OR NUCLEIC ACID AMP FOR DETECTION OF HCV RNA, HIV RNA QHO ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG J17239

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown