BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® DPX - 192T

    MDR report key: 23075320 · Received September 17, 2025

    Report

    Report Number
    2243471-2025-03022
    Event Type
    Malfunction
    Date Received
    September 17, 2025
    Date of Event
    June 1, 2024
    Report Date
    September 17, 2025
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG
    Product Code
    QHO
    PMA / PMN Number
    BL125576
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT OCCURRED ON A COBAS 6800 SYSTEM (SERIAL NUMBER: (B)(6)). THE INVESTIGATION DETERMINED THAT THE COBAS DPX ASSAY (LOT K21753) AND THE COBAS 6800 SYSTEM WERE PERFORMING WITHIN SPECIFICATIONS. AN ANALYSIS OF THE CUSTOMER-PROVIDED DATA, INCLUDING PCR GROWTH CURVES AND CYCLE THRESHOLD (CT) VALUES, CONFIRMED ACCURATE POSITIVE CALLS AND NO ANOMALIES IN THE ALGORITHM THAT COULD LEAD TO ERRONEOUS OUTCOMES. QUALITY CONTROL DATA, INCLUDING ROBUST AMPLIFICATION CURVES FOR THE INTERNAL CONTROL (IC), QUANTITATION STANDARD (QS), AND TARGETS, INDICATED PROPER FUNCTIONING OF THE PCR AND SAMPLE PREPARATION PROCESSES. THE DISCREPANT PARVOVIRUS B19 (PARVO B19) RESULTS WERE ATTRIBUTED TO VERY LOW VIRAL LOADS NEAR OR BELOW THE TEST'S LIMIT OF DETECTION (LOD), WHICH CAN CAUSE VARIABILITY IN RESULTS AND FLUCTUATIONS BETWEEN REACTIVE AND NON-REACTIVE OUTCOMES. THIS BEHAVIOR IS CONSISTENT WITH THE EXPECTED PERFORMANCE OF THE ASSAY AS DESCRIBED IN THE INSTRUCTIONS FOR USE (IFU). NO EVIDENCE OF A PRODUCT-RELATED ISSUE WAS IDENTIFIED, AND NO SIGNS OF HARDWARE-RELATED MALFUNCTIONS WERE OBSERVED.

    Description of Event or Problem · 0

    THE INITIAL REPORTER ALLEGED DISCREPANT PARVOVIRUS B19 (PARVO B19) RESULTS USING THE KIT COBAS 58/68/8800 DPX 192T CE-IVD ASSAY ON THE COBAS 6800 SYSTEM. THE CUSTOMER REPORTED THAT THE PRIMARY POOL OF 6 (PP6) GENERATED NON-REACTIVE RESULTS FOR PARVO B19, WHILE ASSOCIATED POOLS, EVEN AT HIGHER DILUTIONS, GENERATED REACTIVE RESULTS. DATA PROVIDED BY THE CUSTOMER INCLUDED THE FOLLOWING RESULTS: - RUN 7272: THREE PP6 POOLS WERE REACTIVE FOR PARVO B19 WITH CYCLE THRESHOLD (CT) VALUES OF 40, 37.5, AND 29, WITH CORRESPONDING TITERS OF BELOWTITERMIN 40 IU/ML AND 14,391 IU/ML. ALL OTHER PP6 POOLS WERE NON-REACTIVE FOR PARVO B19. - RUN 7274: NON-REACTIVE PP6 SAMPLES WERE POOLED INTO PP96 POOLS FOR REPEAT TESTING. TWO PP96 POOLS WERE REACTIVE FOR PARVO B19 WITH CT VALUES OF 39.9 AND 41, BOTH BELOWTITERMIN 40 IU/ML. - RUN 7278: RESOLUTION OF PP96 POOLS INTO SECONDARY POOL OF 12 (SP12) REVEALED FOUR REACTIVE SP12 POOLS WITH CT VALUES OF 39.2, 36.2, 40.9, AND 37.9, WITH TITERS OF BELOWTITERMIN 40 IU/ML AND 91.2 IU/ML. - RUN 7280: INDIVIDUAL SAMPLES TESTED REACTIVE FOR PARVO B19 WITH CT VALUES RANGING FROM 34.9 TO 39.2, ALL BELOWTITERMIN 40 IU/ML. - RUN 7286: ALL SAMPLES GENERATED VALID AND NON-REACTIVE RESULTS FOR PARVO B19.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1705360 COBAS® DPX - 192T ASSAY, HYB AND/OR NUCLEIC ACID AMP FOR DETECTION OF HCV RNA, HIV RNA QHO ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG K21753

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown