BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® MPX - 96T

    MDR report key: 23075688 · Received September 17, 2025

    Report

    Report Number
    2243471-2025-03025
    Event Type
    Malfunction
    Date Received
    September 17, 2025
    Date of Event
    July 3, 2024
    Report Date
    September 17, 2025
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG
    Product Code
    QHO
    PMA / PMN Number
    BL125576
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 KIT COBAS 6800/8800 MPX 96T CE-IVD ASSAY PERFORMED WITHIN SPECIFICATIONS. NO SYSTEMIC PRODUCT ISSUE WAS IDENTIFIED, AND THIS APPEARS TO BE AN ISOLATED INCIDENT. A REVIEW OF THE PROVIDED RUN FILES CONFIRMED THE ACCURACY OF THE RESULT CALL, WITH NO ANOMALIES DETECTED IN THE PCR GROWTH CURVES OR ALGORITHM PERFORMANCE. THE CYCLE THRESHOLD (CT) VALUE OF 38.51 FOR THE HBV REACTIVE RESULT WAS CONSISTENT WITH A WEAK PCR SIGNAL. QUALITY CONTROL DATA AND WORLDWIDE CUSTOMER REAL-TIME DATA FOR LOT K20768 DID NOT INDICATE ANY PRODUCT-RELATED ISSUES. THE AVAILABLE DATA SUGGESTS THAT THE OBSERVED HBV REACTIVE RESULT MAY BE ATTRIBUTED TO PRE-ANALYTICAL LOW VIRAL LOAD CONTAMINATION OF THE SAMPLE OR A FALSE NEGATIVE FROM THE SEROLOGY TEST. THE DEVICE REMAINS IN OPERATION AT THE CUSTOMER SITE.

    Description of Event or Problem · 0

    THE INITIAL REPORTER QUESTIONED A REACTIVE HEPATITIS B VIRUS (HBV) RESULT OBTAINED USING THE KIT COBAS 6800/8800 MPX 96T CE-IVD ASSAY ON THE COBAS 6800 INSTRUMENT. THE HBV REACTIVE RESULT WAS GENERATED ON (B)(6) 2024 FOR SAMPLE ID (B)(6) DURING ROUTINE BLOOD DONATION SCREENING. THE RESULT WAS DEEMED VALID, WITH A CYCLE THRESHOLD (CT) VALUE OF 38.51. A SUBSEQUENT SEROLOGY TEST FOR HEPATITIS B SURFACE ANTIGEN (HBSAG) WAS PERFORMED, YIELDING A NEGATIVE RESULT. AS A RESULT OF THE HBV REACTIVE RESULT, THE ASSOCIATED BLOOD DONATION WAS DISCARDED. NO HARM WAS REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2639756 COBAS® MPX - 96T ASSAY, HYB AND/OR NUCLEIC ACID AMP FOR DETECTION OF HCV RNA, HIV RNA QHO ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG K20768

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown