BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® WNV (192T)

    MDR report key: 23111312 · Received September 22, 2025

    Report

    Report Number
    2243471-2025-03365
    Event Type
    Malfunction
    Date Received
    September 22, 2025
    Date of Event
    December 5, 2024
    Report Date
    September 22, 2025
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG
    Product Code
    QHO
    PMA / PMN Number
    BL125575
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ANALYSIS WAS PERFORMED ON A COBAS 8800 INSTRUMENT (SERIAL NUMBER: (B)(6). THE INVESTIGATION DETERMINED THAT THE COBAS WNV ASSAY PERFORMED WITHIN SPECIFICATIONS, WITH NO ANOMALIES IDENTIFIED IN THE ALGORITHM, HARDWARE, OR ASSAY LOT: K25276. A REVIEW OF QUALITY CONTROL DATA REVEALED NO ISSUES RELATED TO THE REPORTED EVENT. THE INVESTIGATION CONCLUDED THAT THE REACTIVE RESULT MAY HAVE BEEN CAUSED BY CROSS-REACTIVITY DUE TO NUCLEOTIDE SEQUENCE HOMOLOGY BETWEEN WEST NILE VIRUS (WNV) AND OTHER CLINICALLY RELEVANT VIRUSES IN THE FLAVIVIRIDAE FAMILY, SUCH AS JAPANESE ENCEPHALITIS VIRUS (JEV). THE DONOR'S RECENT ADMINISTRATION OF AN INACTIVATED WHOLE-VIRUS JEV VACCINE SHORTLY BEFORE DONATION MAY HAVE CONTRIBUTED TO THE OBSERVED RESULT. THE DEVICE REMAINS IN OPERATION AT THE CUSTOMER SITE, AND NO SYSTEMIC PRODUCT ISSUE WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE INITIAL REPORTER QUESTIONED A REACTIVE RESULT OBTAINED WITH THE KIT COBAS 58/68/8800 WNV 192T CE-IVD ASSAY ON THE COBAS 8800 INSTRUMENT. THE REACTIVE RESULT FOR WEST NILE VIRUS (WNV) WAS GENERATED. THE RESULT APPEARED LEGITIMATE BASED ON CURVE ANALYSIS. CONFIRMATORY TESTING WAS CONDUCTED BY THE NATIONAL REFERENCE LABORATORY AND WAS REPORTED AS NEGATIVE. HOWEVER, FURTHER SAMPLES TESTED ON (B)(6) 2024 WERE ALL REACTIVE. CONFIRMATORY TESTING WAS LIKELY PERFORMED ON THE GRIFOLS PANTHER SYSTEM. THE DONOR DISCLOSED THAT THEY HAD RECEIVED A JAPANESE ENCEPHALITIS VIRUS (JEV) VACCINE A FEW HOURS PRIOR TO DONATION. SPECIFIC POLYMERASE CHAIN REACTION (PCR) TESTS FOR USUTU VIRUS AND JEV ARE BEING CONDUCTED BY THE RARE AND IMPORTED PATHOGENS LABORATORY (RIPL) TO INVESTIGATE POTENTIAL CROSS-REACTIVITY. BOTH WNV AND JEV BELONG TO THE FLAVIVIRUS GENUS AND SHARE GENETIC AND ANTIGENIC SIMILARITIES, WHICH MAY CONTRIBUTE TO CROSS-REACTIVITY IN THE ASSAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2526959 COBAS® WNV (192T) NUCLEIC-ACID TESTS FOR INFECTIOUS DISEASE SCREENING OF BLOOD & PLASMA DONATIONS QHO ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG K25276

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown