BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® WNV NUCLEIC ACID TEST FOR USE ON THE COBAS® 6800/8800 SYSTEMS

    MDR report key: 23099626 · Received September 19, 2025

    Report

    Report Number
    2243471-2025-03259
    Event Type
    Malfunction
    Date Received
    September 19, 2025
    Date of Event
    September 7, 2024
    Report Date
    September 19, 2025
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG
    Product Code
    QHO
    UDI-DI
    00875197004977
    PMA / PMN Number
    BL125575
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT OCCURRED ON A COBAS 8800 SYSTEM (SERIAL NUMBER: (B)(6)). THE INVESTIGATION DETERMINED THAT THE COBAS WNV ASSAY PERFORMED WITHIN SPECIFICATIONS, AND NO PRODUCT OR HARDWARE ISSUE WAS IDENTIFIED WITH THE COBAS WNV LOTS K21541 OR M01062. A REVIEW OF THE PROVIDED DATA REVEALED WEAK WNV PCR CURVES WITH LATE CYCLE THRESHOLD (CT) VALUES, WHILE THE INTERNAL CONTROL (IC) CURVES WERE ROBUST. THE OBSERVED VARIABILITY BETWEEN REACTIVE AND NON-REACTIVE RESULTS IS MOST LIKELY ATTRIBUTABLE TO A VERY LOW VIRAL LOAD, NEAR OR BELOW THE TEST'S LIMIT OF DETECTION (LOD). THIS IS CONSISTENT WITH THE EXPECTED VARIABILITY IN REACTIVITY RATES FOR LOW VIRAL LOAD SAMPLES, AS OUTLINED IN THE ASSAY'S INSTRUCTIONS FOR USE (IFU). THE DEVICE REMAINS IN OPERATION AT THE CUSTOMER SITE, AND NO FURTHER ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 0

    THE INITIAL REPORTER ALLEGED DISCREPANT RESULTS WITH THE KIT COBAS 6800/8800 WNV 480T IVD ASSAY ON THE COBAS 8800 SYSTEM. THE ALLEGATION INVOLVES MULTIPLE WEST NILE VIRUS (WNV) SAMPLES THAT INITIALLY TESTED REACTIVE BUT TURNED NON-REACTIVE UPON RETESTING. DATA PROVIDED BY THE CUSTOMER SHOWED WEAK WNV POLYMERASE CHAIN REACTION (PCR) CURVES WITH LATE CYCLE THRESHOLD (CT) VALUES, WHILE THE INTERNAL CONTROL (IC) CURVES WERE ROBUST. SPECIFIC EXAMPLES INCLUDE: - SAMPLE ID (B)(6): WNV CURVE 39.11, IC CURVE 34.76. - SAMPLE ID (B)(6): WNV CURVE 39.53, IC CURVE 35.78. - SAMPLE ID (B)(6): WNV CURVE 38.47, IC CURVE 34.62. - SAMPLE ID (B)(6): WNV CURVE 39.19, IC CURVE 35.1. - SAMPLE ID (B)(6): WNV CURVE 39.35, IC CURVE 35.15. THE RESULTS WERE QUESTIONED DUE TO THE OBSERVED VARIABILITY BETWEEN REACTIVE AND NON-REACTIVE OUTCOMES FOR THE SAME SAMPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1398120 COBAS® WNV NUCLEIC ACID TEST FOR USE ON THE COBAS® 6800/8800 SYSTEMS NUCLEIC-ACID TESTS FOR INFECTIOUS DISEASE SCREENING OF BLOOD & PLASMA DONATIONS QHO ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG M01062 00875197004977

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown