BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS TAQSCREEN MPX TEST V2

    MDR report key: 23135034 · Received September 24, 2025

    Report

    Report Number
    2243471-2025-03565
    Event Type
    Malfunction
    Date Received
    September 24, 2025
    Date of Event
    February 27, 2021
    Report Date
    September 24, 2025
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG
    Product Code
    QHO
    PMA / PMN Number
    BL125459
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ANALYSIS WAS PERFORMED ON A COBAS TAQMAN INSTRUMENT (SERIAL NUMBER: (B)(6). THE INVESTIGATION DETERMINED THAT THE KIT S201 T-SCRN MPX V2.0 96T CE-IVD ASSAY PERFORMED WITHIN SPECIFICATIONS. THE HCV CYCLE THRESHOLD (CT) VALUE OF 43.4 OBSERVED IN THE REPORTED CASE ALIGNS WITH VALUES SEEN AT THE LIMIT OF DETECTION (LOD) DURING QUALITY CONTROL RELEASE TESTING. LATE CT VALUES SUCH AS THIS CAN INDICATE A VIRAL LOAD BELOW THE ASSAY'S LOD, WHERE RESULTS MAY FLUCTUATE BETWEEN REACTIVE AND NON-REACTIVE. SEROLOGY TESTING AND REPEAT TESTING USING AN ALTERNATIVE METHOD CONFIRMED NON-REACTIVE RESULTS FOR ALL TARGETS. THE INVESTIGATION DID NOT IDENTIFY ANY ISSUES WITH ROCHE REAGENTS. A POTENTIAL CAUSE OF THE REACTIVE RESULT COULD BE NON-SPECIFIC AMPLIFICATION, POSSIBLY DUE TO ENVIRONMENTAL CONTAMINANTS DURING SAMPLE HANDLING; HOWEVER, THIS COULD NOT BE CONFIRMED AS GROWTH CURVE DATA WAS NOT AVAILABLE FOR REVIEW. THE DEVICE REMAINED IN OPERATION AT THE CUSTOMER SITE, AND NO ADVERSE EVENTS OR DELAYS IN TREATMENT WERE REPORTED.

    Description of Event or Problem · 0

    THE INITIAL REPORTER ALLEGED DISCREPANT RESULTS USING THE KIT S201 T-SCRN MPX V2.0 96T CE-IVD ASSAY ON THE COBAS TAQMAN INSTRUMENT. THE CUSTOMER GENERATED A REACTIVE HEPATITIS C VIRUS (HCV) RESULT WITH A CYCLE THRESHOLD (CT) VALUE OF 43.4 USING THE MPX V2.0 ASSAY ON THE COBAS TAQMAN INSTRUMENT. REPEAT TESTING OF THE SAME SAMPLE WAS PERFORMED USING THE CEPHEID GENEXPERT SYSTEM, WHICH GENERATED A NON-REACTIVE RESULT FOR ALL TARGETS. SEROLOGY TESTING WAS ALSO CONFIRMED TO BE NON-REACTIVE FOR ALL TARGETS. BLOOD WAS NOT RELEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2384275 COBAS TAQSCREEN MPX TEST V2 HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 (HIV-1) GROUP M AND O RNA, HIV-2 RNA, HCV QHO ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG F26722

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown