BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® DPX - 192T

    MDR report key: 23135634 · Received September 24, 2025

    Report

    Report Number
    2243471-2025-03599
    Event Type
    Malfunction
    Date Received
    September 24, 2025
    Date of Event
    November 4, 2024
    Report Date
    September 24, 2025
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG
    Product Code
    QHO
    PMA / PMN Number
    BL125576
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT OCCURRED ON A COBAS 6800 ANALYZER (SERIAL NUMBER: (B)(6). THE INVESTIGATION DETERMINED THAT NO ISSUES WITH THE REAGENT LOT OR INSTRUMENT WERE IDENTIFIED. THE COBAS DPX TEST KIT WAS CONFIRMED TO BE PERFORMING WITHIN SPECIFICATIONS. A REVIEW OF THE PROVIDED RUN DATA FOR BATCH 1806 SHOWED CONSISTENT STRONG POSITIVE AMPLIFICATION FOR B19 DNA ACROSS ALL THREE RUNS OF SAMPLE ID (B)(6), DESPITE INVALID RESULTS DUE TO HAV (TH01 FLAG). NO ABNORMALITIES WERE IDENTIFIED IN THE REAGENT LOT OR IN THE RFI VS. F-VALUE DISTRIBUTION ACROSS MULTIPLE DPX BATCHES. THE ISSUE IS LIKELY ATTRIBUTABLE TO PRE-ANALYTIC CONTAMINATION OR A SAMPLE-SPECIFIC FACTOR, SUCH AS A SAMPLE MIX-UP OR CONTAMINATION DURING THE POOLING PROCESS. A DEFINITIVE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED BASED ON THE AVAILABLE INFORMATION.

    Description of Event or Problem · 0

    THE INITIAL REPORTER ALLEGED DISCREPANT RESULTS WHEN USING THE KIT COBAS 58/68/8800 DPX 192T CE-IVD ON THE COBAS 6800 INSTRUMENT. THE CUSTOMER, A PLASMA FACTORY, TESTS BLOOD BAGS IN POOLS OF 480. SAMPLES WITH NEGATIVE RESULTS FOR B19 AND HEPATITIS A VIRUS (HAV) ARE COMBINED INTO TANKS FOR PROCESSING. BEFORE PRODUCTION, A TRIPLICATE ALIQUOT IS RETESTED. IN THIS CASE, A PRODUCTION POOL THAT HAD BEEN PRE-SCREENED AS NEGATIVE IN POOLS OF 480 WAS REPORTED AS POSITIVE FOR B19 DNA WITH A CONCENTRATION OF E+008 IU/ML. RUN DATA FOR BATCH 1806 SHOWED THREE RUNS FOR SAMPLE ID (B)(6). EACH RUN (B)(6) GENERATED AN INVALID RESULT DUE TO HAV (TH01 FLAG, INVALID QUALIFICATION RESULT) BUT SHOWED STRONG POSITIVE AMPLIFICATION FOR B19 DNA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1824635 COBAS® DPX - 192T ASSAY, HYB AND/OR NUCLEIC ACID AMP FOR DETECTION OF HCV RNA, HIV RNA QHO ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG M06065

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown