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: 23094362 · Received September 19, 2025

    Report

    Report Number
    2243471-2025-03167
    Event Type
    Malfunction
    Date Received
    September 19, 2025
    Date of Event
    December 5, 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 REPORTED EVENT OCCURRED ON A COBAS S201 INSTRUMENT WITH 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, INCLUDING RAW DATA AND LIMIT OF DETECTION (LOD) TESTING RESULTS, INDICATED THAT THE OBSERVED DISCREPANCIES IN HBV RESULTS WERE LIKELY DUE TO THE EXTERNAL QUALITY CONTROL MATERIAL BEING DILUTED NEAR THE ASSAY'S LOD. CONCENTRATIONS NEAR THE LOD MAY NOT YIELD CONSISTENT RESULTS, AND VARIABILITY IN SAMPLE PREPARATION AND DILUTION WAS IDENTIFIED AS A CONTRIBUTING FACTOR. INSTRUMENT PERFORMANCE CHECKS, INCLUDING INTERNAL AND QUALITY CONTROLS, WERE WITHIN EXPECTED RANGES, AND NO ISSUES WERE IDENTIFIED WITH THE SYSTEM. NO PRODUCT ISSUE WAS IDENTIFIED, AND THE ROOT CAUSE WAS ATTRIBUTED TO THE EXTERNAL MATERIAL'S PREPARATION AND ITS PROXIMITY TO THE ASSAY'S LOD. THE DEVICE REMAINS IN OPERATION AT THE CUSTOMER SITE.

    Description of Event or Problem · 0

    THE INITIAL REPORTER ALLEGED DISCREPANT RESULTS FOR THE HBV TARGET USING THE KIT S201 T-SCRN MPX V2.0 96T US-IVD ASSAY ON THE COBAS S201 INSTRUMENT. THE CUSTOMER ALSO REPORTED A YEAR-OVER-YEAR DECLINE IN HBV POSITIVE RATES FROM 2020 TO 2023, RAISING CONCERNS ABOUT POTENTIAL FALSE NEGATIVE RESULTS. THE CUSTOMER CONDUCTED A LIMIT OF DETECTION (LOD) TEST FOR HIV, HBV, AND HCV TARGETS USING EXTERNAL MATERIAL FROM AN UNKNOWN THIRD-PARTY SUPPLIER. THE MATERIAL WAS DILUTED TO 1XLOD FOR EACH TARGET, WITH THE HBV TARGET SHOWING DISCREPANCIES. SPECIFICALLY, FOR THE FIRST BATCH OF TESTING, TWO SAMPLES ((B)(6)) WERE UNEXPECTEDLY NEGATIVE. THE EXTERNAL MATERIAL HAD A PRIMARY CONCENTRATION OF 50 IU/ML AND WAS DILUTED TO 2.5 IU/ML, WHICH IS NEAR THE ASSAY'S LOD OF 2.3 IU/ML. THE CUSTOMER NOTED THAT FOR LOD TESTING, THE VALIDITY CRITERIA REQUIRE 18 OUT OF 20 POOLS TO BE POSITIVE. THE CUSTOMER OBSERVED VARIATION IN HBV CYCLE THRESHOLD (CT) VALUES DURING THE FIRST BATCH OF TESTING, WITH VALUES RANGING FROM 35.7 TO 38.5, WHICH COINCIDED WITH THE FALSE NEGATIVE RESULTS. IN CONTRAST, THE SECOND BATCH OF TESTING SHOWED CONSISTENT CT VALUES WITH NO FALSE NEGATIVE RESULTS. THE INTERNAL CONTROLS AND QUALITY CONTROLS (IC/QC) FOR BOTH BATCHES WERE SIMILAR. THE RESULTS FOR THE HIV AND HCV TARGETS SHOWED LESS VARIATION, WITH HCV DEMONSTRATING THE MOST CONSISTENT DATA AMONG THE THREE TARGETS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1766927 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 J11215 00875197004045

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown