BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® TAQSCREEN MPX TEST, VERSION 2.0 FOR USE ON THE COBAS S 201 SYSTEM

    MDR report key: 23085560 · Received September 18, 2025

    Report

    Report Number
    2243471-2025-03115
    Event Type
    Malfunction
    Date Received
    September 18, 2025
    Date of Event
    July 19, 2022
    Report Date
    September 18, 2025
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG
    Product Code
    QHO
    UDI-DI
    00875197004045
    PMA / PMN Number
    BL125459
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ANALYSIS WAS PERFORMED ON A COBAS AMPLIPREP INSTRUMENT (SERIAL NUMBER: (B)(6)). THE INVESTIGATION DETERMINED THAT THE KIT S201 T-SCRN MPX V2.0 96T US-IVD ASSAY WAS PERFORMING WITHIN SPECIFICATIONS. DATA ANALYSIS INDICATED THAT THE REACTIVE RESULT WITH A CYCLE THRESHOLD (CT) VALUE OF 36.9 WAS CHARACTERISTIC OF A SAMPLE WITH A VIRAL CONCENTRATION NEAR THE LIMIT OF DETECTION (LOD) OF THE ASSAY. SUCH SAMPLES MAY PRODUCE WAVERING RESULTS BETWEEN REACTIVE AND NON-REACTIVE, WHICH IS AN EXPECTED BEHAVIOR AT LOW VIRAL CONCENTRATIONS. POSITIVE CONTROL TARGETS WERE ROBUST AND SIGMOIDAL, CONFIRMING PROPER ASSAY PERFORMANCE. THE MOST LIKELY CAUSE OF THE DISCREPANT RESULTS WAS ATTRIBUTED TO THE SAMPLE'S VIRAL CONCENTRATION BEING NEAR THE LOD. CLINICALLY, THE CAUSE COULD NOT BE DETERMINED AS DONOR HISTORY AND SEROLOGY RESULTS WERE NOT PROVIDED. THE DONATION BAG ASSOCIATED WITH THE SAMPLE WAS DISCARDED, AND NO HARM OR DELAY IN TREATMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE INITIAL REPORTER ALLEGED AN UNEXPECTED REACTIVE RESULT FOR HEPATITIS B VIRUS (HBV) WHEN USING THE KIT S201 T-SCRN MPX V2.0 96T US-IVD ASSAY ON THE COBAS AMPLIPREP INSTRUMENT. A PLASMA SAMPLE FOR BLOOD DONATION WAS TESTED AS AN INDIVIDUAL DONATION TEST (IDT) AND GENERATED A REACTIVE HBV RESULT WITH A CYCLE THRESHOLD (CT) VALUE OF 36.9. REPEAT TESTING FROM THE SAME TUBE WAS NON-REACTIVE. A NEW SAMPLE FROM THE SAME DONOR WAS TESTED AND WAS ALSO NON-REACTIVE. SEROLOGY RESULTS FOR THE SAMPLE WERE NOT PROVIDED. THE DONATION BAG ASSOCIATED WITH THE SAMPLE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2873993 COBAS® TAQSCREEN MPX TEST, VERSION 2.0 FOR USE ON THE COBAS S 201 SYSTEM HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 (HIV-1) GROUP M AND O RNA, HIV-2 RNA, HCV QHO ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG H19097 00875197004045

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown