BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® BABESIA NUCLEIC ACID TEST FOR USE ON THE COBAS® 6800/8800 SYSTEMS

    MDR report key: 23157948 · Received September 26, 2025

    Report

    Report Number
    2243471-2025-03850
    Event Type
    Malfunction
    Date Received
    September 26, 2025
    Date of Event
    December 19, 2023
    Report Date
    September 26, 2025
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG
    Product Code
    QHO
    PMA / PMN Number
    BL125699
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ANALYSIS WAS PERFORMED ON A COBAS 8800 ANALYZER (SERIAL NUMBER: (B)(6)). THE INVESTIGATION DETERMINED THAT THE COBAS BABESIA ASSAY PERFORMED WITHIN SPECIFICATIONS, AND NO PRODUCT ISSUE WAS IDENTIFIED. A REVIEW OF THE INTERNAL CONTROL (IC) AND RUN CONTROL (RMC) DATA INDICATED NO SUPPRESSED GROWTH CURVES OR ABNORMALITIES, SUGGESTING THAT THE ASSAY AND ANALYZER FUNCTIONED AS EXPECTED. THE OBSERVATIONS POINT TOWARDS A POTENTIAL SAMPLE-SPECIFIC FACTOR AS THE CAUSE OF THE DISCREPANCY. CONTRIBUTING FACTORS SUCH AS IMPROPER SAMPLE HANDLING, STORAGE CONDITIONS, OR RARE GENETIC MUTATIONS IN THE BABESIA RRNA GENE THAT COULD AFFECT PCR AMPLIFICATION WERE CONSIDERED BUT COULD NOT BE CONFIRMED. ADDITIONALLY, THE TRUE INFECTION STATUS OF THE DONOR REMAINS UNKNOWN, AND A FALSE POSITIVE RESULT FROM THE GRIFOLS PANTHER ASSAY CANNOT BE DEFINITIVELY RULED OUT. FURTHER INVESTIGATION WAS NOT POSSIBLE AS THE SAMPLES WERE NO LONGER AVAILABLE. THE INVESTIGATION INTO THE COBAS BABESIA LOT K06449 DID NOT IDENTIFY ANY ISSUES, AND THE DEVICE REMAINS IN OPERATION AT THE CUSTOMER SITE.

    Description of Event or Problem · 0

    THE INITIAL REPORTER ALLEGED DISCREPANT RESULTS WHEN USING THE KIT COBAS 6800/8800 BABESIA 480T IVD ON THE COBAS 8800 INSTRUMENT. THE DONOR SAMPLES WERE TESTED, WITH SAMPLE ID (B)(6) COLLECTED ON (B)(6)2023 AND SAMPLE ID (B)(6) COLLECTED ON (B)(6)2023. BOTH SAMPLES WERE REPORTED AS NON-REACTIVE WITH THE COBAS BABESIA ASSAY BUT WERE REACTIVE WITH THE GRIFOLS ASSAY. ADDITIONALLY, THREE DIFFERENT POSITIVE CONTROLS PROVIDED BY THE CUSTOMER YIELDED EXPECTED POSITIVE RESULTS. THE INTERNAL CONTROL (IC) OF THE ALLEGED SAMPLES DID NOT SHOW A SUPPRESSED GROWTH CURVE, AND THE RUN CONTROLS (RMC) ALSO APPEARED UNAFFECTED, DISPLAYING SIGMOIDAL GROWTH CURVES FOR BOTH THE TARGET AND IC CHANNELS. THESE OBSERVATIONS SUGGEST A POTENTIAL SAMPLE-SPECIFIC FACTOR RATHER THAN AN ISSUE WITH THE COBAS BABESIA ASSAY OR THE ANALYZER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2244912 COBAS® BABESIA NUCLEIC ACID TEST FOR USE ON THE COBAS® 6800/8800 SYSTEMS NUCLEIC-ACID TESTS FOR INFECTIOUS DISEASE SCREENING OF BLOOD & PLASMA DONATIONS QHO ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG K06449

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown