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: 23112013 · Received September 22, 2025

    Report

    Report Number
    2243471-2025-03388
    Event Type
    Malfunction
    Date Received
    September 22, 2025
    Date of Event
    December 13, 2021
    Report Date
    September 22, 2025
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG
    Product Code
    QHO
    PMA / PMN Number
    BL125459
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT OCCURRED ON A COBAS AMPLIPREP INSTRUMENT WITH SERIAL NUMBER (B)(6). THE INVESTIGATION DETERMINED THAT THE KIT S201 T-SCRN MPX V2.0 96T US-IVD PERFORMED WITHIN SPECIFICATIONS. A REVIEW OF THE DATA INDICATED THAT THE CYCLE THRESHOLD (CT) VALUES GENERATED WERE DELAYED, SUGGESTING THAT THE SAMPLES HAD A VIRAL LOAD NEAR OR BELOW THE TEST'S LIMIT OF DETECTION (LOD). SAMPLES NEAR OR BELOW THE LOD MAY PRODUCE WAVERING RESULTS. ADDITIONALLY, LOW-LEVEL CONTAMINATION AT THE CUSTOMER SITE COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR. NO PRODUCT-RELATED ISSUE WAS IDENTIFIED. SEROLOGY RESULTS FOR ALL RUNS WERE NEGATIVE, AND NO BLOOD WAS RELEASED. A REVIEW OF COMPLAINT HISTORY AND NON-CONFORMANCE RECORDS DID NOT IDENTIFY ANY TRENDS OR RELATED ISSUES. THE DEVICE REMAINS IN OPERATION AT THE CUSTOMER SITE.

    Description of Event or Problem · 0

    THE INITIAL REPORTER ALLEGED DISCREPANT RESULTS WHILE USING THE KIT S201 T-SCRN MPX V2.0 96T US-IVD ON THE COBAS AMPLIPREP INSTRUMENT. THE ALLEGATION INVOLVES MULTIPLE RUNS WITH VARYING RESULTS. ON (B)(6) 2021, A SAMPLE WITH BARCODE (B)(6) WAS REACTIVE FOR HEPATITIS C VIRUS (HCV) WITH A CYCLE THRESHOLD (CT) VALUE OF 41.8. RESOLUTION TESTING OF THE SAME SAMPLE (B)(6) SHOWED HCV REACTIVE WITH A CT VALUE OF 48.1 ON THE FIRST RETEST AND NON-REACTIVE ON THE SECOND RETEST. ANOTHER SAMPLE (B)(6) WAS REACTIVE FOR HUMAN IMMUNODEFICIENCY VIRUS (HIV) WITH A CT VALUE OF 42 ON THE FIRST RETEST AND HCV REACTIVE WITH A CT VALUE OF 42.5 ON THE SECOND RETEST. ON (B)(6) 2021, A SAMPLE WITH BARCODE(B)(6) WAS REACTIVE FOR HIV WITH A CT VALUE OF 47.3. RESOLUTION TESTING OF THE SAME SAMPLE (B)(6) SHOWED HCV REACTIVE WITH A CT VALUE OF 51.3 ON THE FIRST RETEST AND NON-REACTIVE ON THE SECOND RETEST. ANOTHER SAMPLE (B)(6) WAS REACTIVE FOR BOTH HIV (CT 47) AND HCV (CT 38.1) ON THE FIRST RETEST AND NON-REACTIVE ON THE SECOND RETEST. ON (B)(6) 2021, A SAMPLE WITH BARCODE (B)(6) WAS REACTIVE FOR HCV WITH A CT VALUE OF 46.5, AND RESOLUTION TESTING SHOWED NON-REACTIVE RESULTS. ANOTHER SAMPLE WITH BARCODE (B)(6) WAS REACTIVE FOR BOTH HIV (CT 43.0) AND HCV (CT 51.4), AND RESOLUTION TESTING SHOWED NON-REACTIVE RESULTS. A THIRD SAMPLE WITH BARCODE (B)(6) WAS REACTIVE FOR HIV WITH A CT VALUE OF 44.7, AND RESOLUTION TESTING SHOWED NON-REACTIVE RESULTS. FOR ALL THE RUNS MENTIONED ABOVE, SEROLOGY RESULTS WERE NEGATIVE. BLOOD WAS NOT RELEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2026719 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 H06830

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown