BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® MPX - 480T

    MDR report key: 23136841 · Received September 24, 2025

    Report

    Report Number
    2243471-2025-03620
    Event Type
    Malfunction
    Date Received
    September 24, 2025
    Date of Event
    May 15, 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 ANALYSIS WAS PERFORMED ON A COBAS 6800 ANALYZER (SERIAL NUMBER: (B)(6)). THE INVESTIGATION DETERMINED THAT THE COBAS MPX ASSAY (LOT K00715) PERFORMED WITHIN SPECIFICATIONS. A REVIEW OF THE PROVIDED DATA, INCLUDING QUALITY CONTROL AND WORLDWIDE REAL-TIME DATA FOR LOT K00715, DID NOT INDICATE A PRODUCT ISSUE. THE INVESTIGATION FINDINGS SUGGEST THAT A TEMPORARY HIV CONTAMINATION OF EITHER THE CONSUMABLES, THE SYSTEM, OR THE LABORATORY ENVIRONMENT WAS THE MOST LIKELY CAUSE OF THE REPORTED INCREASE IN HIV REACTIVE RESULTS. THE RETURN OF HIV REACTIVE RATES TO EXPECTED LEVELS FURTHER SUPPORTS THIS CONCLUSION. NO ISSUES RELATED TO THE CUSTOMER ALLEGATION WERE IDENTIFIED, AND THE INVESTIGATION DID NOT REVEAL ANY PRODUCT-RELATED CONCERNS.

    Description of Event or Problem · 0

    THE INITIAL REPORTER ALLEGED A DISCREPANT HIV RESULT USING THE KIT COBAS 58/68/8800 MPX 480T IVD ON THE COBAS 6800 INSTRUMENT. A CUSTOMER IN ITALY REPORTED AN INCREASE IN HIV REACTIVE RESULTS FOR AN IDT SAMPLE TESTED WITH THE COBAS MPX ASSAY (LOT K00715). THE REPORTED DATA INDICATED THAT 14 OUT OF THE 20 REPORTED HIV REACTIVE CASES WERE ASSOCIATED WITH THE MPX KIT CASSETTE ID (B)(6). THIS OBSERVATION, ALONG WITH THE RETURN OF HIV REACTIVE RATES TO EXPECTED LEVELS, SUGGESTS A TEMPORARY HIV CONTAMINATION OF EITHER THE CONSUMABLES, THE SYSTEM, OR THE LABORATORY ENVIRONMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2493147 COBAS® MPX - 480T ASSAY, HYB AND/OR NUCLEIC ACID AMP FOR DETECTION OF HCV RNA, HIV RNA QHO ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG K00715

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown