BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 23167732 · Received September 29, 2025

    Report

    Report Number
    2243471-2025-03921
    Event Type
    Malfunction
    Date Received
    September 29, 2025
    Date of Event
    July 21, 2021
    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
    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 WNV 96T IVD ASSAY, AS WELL AS THE HEV AND DPX ASSAYS, PERFORMED WITHIN SPECIFICATIONS. A REVIEW OF THE CYCLE THRESHOLD (CT) VALUES FOR THE WNV, HEV, AND DPX ASSAYS INDICATED ALIGNMENT WITH THE 0.5X LIMIT OF DETECTION (LOD) PANEL CT VALUES OBSERVED DURING QUALITY CONTROL RELEASE. THESE LATE CT VALUES ARE CONSISTENT WITH VIRAL LOADS BELOW THE LOD OF THE ASSAYS, WHERE RESULTS MAY FLUCTUATE BETWEEN REACTIVE AND NON-REACTIVE DUE TO THE INHERENT NATURE OF THE TEST. NO BATCH TRENDS WERE IDENTIFIED FOR THE REAGENT LOTS USED, AND NO NON-CONFORMANCE'S OR CHANGE REQUESTS RELATED TO THE REPORTED ISSUE WERE FOUND. THE ROCHE REAGENTS WERE CONFIRMED TO BE FUNCTIONING AS INTENDED AT THE CUSTOMER SITE.

    Description of Event or Problem · 0

    THE INITIAL REPORTER ALLEGED DISCREPANT RESULTS USING THE KIT COBAS 6800/8800 WNV 96T IVD ON THE COBAS 6800 INSTRUMENT. THE FIRST INSTANCE INVOLVED THE WNV ASSAY, WHERE AN INITIAL REACTIVE RESULT WITH A CYCLE THRESHOLD (CT) VALUE OF 40.84 WAS OBTAINED. REPEAT TESTING OF THE SAME SAMPLE GENERATED A NON-REACTIVE RESULT. THE SECOND INSTANCE INVOLVED THE HEV ASSAY, WHERE AN INITIAL NON-REACTIVE RESULT WAS OBTAINED. REPEAT TESTING OF THE SAME SAMPLE GENERATED A REACTIVE RESULT WITH A CT VALUE OF 42.75. THE THIRD INSTANCE INVOLVED THE DPX ASSAY, WHERE AN INITIAL NON-REACTIVE RESULT WAS OBTAINED. REPEAT TESTING OF THE SAME SAMPLE GENERATED A REACTIVE RESULT WITH A CT VALUE OF 38.50. SEROLOGY INFORMATION FOR THE SAMPLES WAS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1408885 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 G23834

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown