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: 23100336 · Received September 19, 2025

    Report

    Report Number
    2243471-2025-03292
    Event Type
    Malfunction
    Date Received
    September 19, 2025
    Date of Event
    March 23, 2023
    Report Date
    September 19, 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
    CH
    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 US-IVD ASSAY PERFORMED WITHIN SPECIFICATIONS. A REVIEW OF THE DATA PROVIDED INDICATED THAT THE TARGET CURVE FOR HIV WAS ROBUST AND SIGMOIDAL, CONSISTENT WITH TRUE VIRAL TARGET AMPLIFICATION. POSITIVE AND INTERNAL CONTROLS ALSO DEMONSTRATED ROBUST AND SIGMOIDAL CURVES, CONFIRMING PROPER ASSAY PERFORMANCE. NO ISSUES WERE IDENTIFIED IN THE QUALITY CONTROL DATA OR THE REAGENT KIT THAT COULD CONTRIBUTE TO THE REPORTED EVENT. THE MOST LIKELY CAUSE OF THE UNEXPECTED NON-REACTIVE RESULT IN THE POOLED SAMPLE (PP6) WAS ATTRIBUTED TO THE VIRAL CONCENTRATION BEING DILUTED TO THE ASSAY'S LIMIT OF DETECTION, WHERE WAVERING RESULTS BETWEEN REACTIVE AND NON-REACTIVE MAY OCCUR. CLINICALLY, THE DONOR MAY REPRESENT A TRUE-POSITIVE HIV CASE WITH SUPPRESSED VIRAL LOAD DUE TO TREATMENT. A TREND ANALYSIS FOR LOT H30808 DID NOT IDENTIFY ANY RELATED ISSUES. THE DONATION WAS NOT USED, AND NO ADDITIONAL HARM OR DELAY IN TREATMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE INITIAL REPORTER ALLEGED DISCREPANT RESULTS WHEN USING THE KIT S201 T-SCRN MPX V2.0 96T US-IVD ASSAY ON THE COBAS TAQMAN INSTRUMENT. ON (B)(6) 2023, A SAMPLE WAS TESTED IN A POOL OF 6 (PP6) AND WAS NON-REACTIVE FOR ALL TARGETS. SEROLOGY TESTING FOR THE SAME SAMPLE WAS REACTIVE FOR HUMAN IMMUNODEFICIENCY VIRUS (HIV). THE SAMPLE WAS SUBSEQUENTLY TESTED IN RESOLUTION (RESP1) AND WAS REACTIVE FOR HIV WITH A CYCLE THRESHOLD (CT) VALUE OF 38. THE SAMPLE WAS LATER TESTED WITH A QUANTITATIVE ASSAY, WHICH DETECTED A LOW CONCENTRATION OF VIRAL TARGET WITH A VALUE OF LESS THAN 20 COPIES PER MILLILITER (CP/ML). THE DONATION WAS BLOOD, AND IT WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1398169 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 H30808 00875197004045

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown