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: 23083222 · Received September 18, 2025

    Report

    Report Number
    2243471-2025-03091
    Event Type
    Malfunction
    Date Received
    September 18, 2025
    Date of Event
    May 20, 2021
    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
    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 MPX V2.0 US-IVD ASSAY PERFORMED WITHIN SPECIFICATIONS. THE NON-REACTIVE RESULTS OBSERVED IN THE POOL OF 6 (PP6) WERE ATTRIBUTED TO THE DILUTION FACTOR, WHICH MAY REDUCE THE SAMPLE CONCENTRATION TO A LEVEL NEAR OR BELOW THE ASSAY'S LIMIT OF DETECTION, LEADING TO RESULTS THAT CAN WAVER BETWEEN REACTIVE AND NON-REACTIVE. A REVIEW OF THE MPX V2.0 ASSAY LOT G11355 DID NOT IDENTIFY ANY REAGENT-RELATED ISSUES. NO TRENDS OR PRIOR RELATED COMPLAINTS WERE IDENTIFIED FOR THIS LOT. CONTROL LOT INFORMATION WAS NOT AVAILABLE FOR FURTHER ANALYSIS. THE CUSTOMER'S ALLEGATION WAS SUBSTANTIATED; HOWEVER, NO HARM WAS REPORTED, AND THE DONATIONS INVOLVED WERE NOT RELEASED. THE EVENT DID NOT RESULT IN AN ORGAN DONATION REJECTION.

    Description of Event or Problem · 0

    THE INITIAL REPORTER ALLEGED DISCREPANT HEPATITIS B VIRUS (HBV) RESULTS USING THE KIT S201 T-SCRN MPX V2.0 96T US-IVD ASSAY ON THE COBAS TAQMAN INSTRUMENT. THE CUSTOMER REPORTED THAT TWO POOLS OF 6 (PP6) TESTED WITH THE MPX V2.0 ASSAY GENERATED NON-REACTIVE RESULTS. HOWEVER, WHEN THE SAME SAMPLES WERE TESTED WITH A COMPETITOR ASSAY IN A POOL OF 8 (PP8), HBV-REACTIVE RESULTS WERE OBTAINED. RESOLUTION TESTING WAS SUBSEQUENTLY PERFORMED, AND HBV-REACTIVE RESULTS WERE GENERATED FOR BOTH THE MPX V2.0 ASSAY AND THE COMPETITOR ASSAY. THE FOLLOWING RESULTS WERE REPORTED FOR THE QUESTIONED SAMPLES: MPX V2.0 ASSAY: PP6 NON-REACTIVE. MPX V2.0 ASSAY: RESOLUTION TEST HBV-REACTIVE. COMPETITOR TEST: PP8 HBV-REACTIVE. COMPETITOR TEST: RESOLUTION TEST HBV-REACTIVE. THE DONATIONS INVOLVED WERE NOT RELEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2598900 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 G11355 00875197004045

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown