BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® MPX - 192T

    MDR report key: 23098184 · Received September 19, 2025

    Report

    Report Number
    2243471-2025-03220
    Event Type
    Malfunction
    Date Received
    September 19, 2025
    Date of Event
    June 6, 2025
    Report Date
    September 19, 2025
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG
    Product Code
    QHO
    PMA / PMN Number
    BL125576
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 KIT COBAS 58/68/8800 MPX 192T CE-IVD ASSAY AND THE COBAS 6800 SYSTEM WERE PERFORMING WITHIN SPECIFICATIONS. A REVIEW OF THE PROVIDED DATA, INCLUDING PCR SIGNAL ANALYSIS AND INTERNAL CONTROL AMPLIFICATION, CONFIRMED THE ACCURACY OF THE RESULT CALLS AND THE ABSENCE OF DETECTABLE HBV DNA IN THE SAMPLES. NO ANOMALIES IN THE ALGORITHM, HARDWARE, SOFTWARE, OR REAGENT QUALITY WERE IDENTIFIED. ADDITIONALLY, A REVIEW OF QUALITY CONTROL DATA AND WORLDWIDE CUSTOMER REAL-TIME DATA FOR LOT M11245 DID NOT INDICATE ANY PRODUCT-RELATED ISSUES. THE FINDINGS SUGGEST THAT THE OBSERVED NON-REACTIVE HBV RESULTS MAY BE ATTRIBUTED TO LOW-LEVEL HBV DNA VIRAL LOAD NEAR THE ASSAY'S LIMIT OF DETECTION. NO SYSTEMIC PRODUCT ISSUE WAS IDENTIFIED, AND THIS APPEARS TO BE AN ISOLATED INCIDENT. THE INVESTIGATION IS CONSIDERED CLOSED.

    Description of Event or Problem · 0

    THE INITIAL REPORTER ALLEGED DISCREPANT HEPATITIS B VIRUS (HBV) RESULTS USING THE KIT COBAS 58/68/8800 MPX 192T CE-IVD ASSAY ON THE COBAS 6800 INSTRUMENT. THREE SAMPLES WERE INVOLVED IN THIS CASE. FOR SAMPLE ID (B)(6), TESTED ON (B)(6) 2025, THE HBSAG RESULT WAS NON-REACTIVE, THE SYNERGY PP6 RESULT WAS NON-REACTIVE (INTERNAL CONTROL (IC) CYCLE THRESHOLD (CT) 37.5), THE SANSURE PP6 RESULT WAS REACTIVE, THE SANSURE INDIVIDUAL DONATION TESTING (IDT) RESULT WAS REACTIVE, AND THE GRIFOLS IDT RESULT WAS NON-REACTIVE. FOR SAMPLE ID (B)(6), TESTED ON (B)(6) 2025, THE HBSAG RESULT WAS NON-REACTIVE, THE SYNERGY PP6 RESULT WAS NON-REACTIVE (IC CT 37.67), THE SANSURE PP6 RESULT WAS REACTIVE, THE SANSURE IDT RESULT WAS REACTIVE, AND THE GRIFOLS IDT RESULT WAS NON-REACTIVE. FOR SAMPLE ID (B)(6), TESTED ON (B)(6) 2025, THE HBSAG RESULT WAS REACTIVE, THE SYNERGY PP6 RESULT WAS NON-REACTIVE (IC CT 38.05), THE SANSURE PP6 RESULT WAS REACTIVE, THE SANSURE IDT RESULT WAS REACTIVE, AND THE GRIFOLS IDT RESULT WAS REACTIVE. THE CUSTOMER REPORTED THAT THE PLASMA SAMPLES DID NOT EXHIBIT ANY ABNORMAL CHARACTERISTICS SUCH AS HEMOLYSIS OR LIPEMIA. NO HARM WAS ALLEGED DUE TO THE DISCREPANT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1398029 COBAS® MPX - 192T ASSAY, HYB AND/OR NUCLEIC ACID AMP FOR DETECTION OF HCV RNA, HIV RNA QHO ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG M11245

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown