BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 23169476 · Received September 29, 2025

    Report

    Report Number
    2243471-2025-03961
    Event Type
    Malfunction
    Date Received
    September 29, 2025
    Date of Event
    October 5, 2023
    Report Date
    September 29, 2025
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG
    Product Code
    QHO
    PMA / PMN Number
    BL125575
    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 8800 ANALYZER (SERIAL NUMBER: (B)(6). THE INVESTIGATION DETERMINED THAT THE COBAS WNV ASSAY WAS PERFORMING WITHIN SPECIFICATIONS. A REVIEW OF THE DATA PROVIDED BY THE CUSTOMER INDICATED THAT THE ASSAY'S POSITIVE AND INTERNAL CONTROLS WERE ROBUST AND SIGMOIDAL, CONFIRMING PROPER ASSAY FUNCTIONALITY. THE CT VALUE OF 36.14 OBSERVED FOR THE REACTIVE RESULT WAS CONSISTENT WITH SAMPLES AT LOWER CONCENTRATIONS THAN THE STATED 6XLOD. ADDITIONALLY, NO ISSUES WERE IDENTIFIED DURING THE QC RELEASE DATA REVIEW, AND NO SYSTEMIC ISSUES WERE OBSERVED FOR THE REAGENT KIT LOT: K00402. THE MOST LIKELY ROOT CAUSE OF THE UNEXPECTED NON-REACTIVE RESULT WAS DETERMINED TO BE SAMPLE-SPECIFIC, POTENTIALLY DUE TO THE SAMPLE NOT BEING PREPARED AT THE STATED 6XLOD CONCENTRATION.

    Description of Event or Problem · 0

    THE INITIAL REPORTER ALLEGED AN UNEXPECTED NON-REACTIVE RESULT FOR WEST NILE VIRUS (WNV) WHEN USING THE KIT COBAS 6800/8800 WNV 96T IVD ASSAY ON A COBAS 8800 INSTRUMENT. THE SAMPLE IN QUESTION WAS STATED TO BE AT A CONCENTRATION OF 6 TIMES THE LIMIT OF DETECTION (6XLOD) AND WAS USED FOR VALIDATION OF THE INSTRUMENT. THE SAMPLE WAS REPEATED ON ANOTHER COBAS INSTRUMENT, WHERE IT GENERATED A REACTIVE RESULT AS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1773403 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 K00402

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown