BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E 411 ANALYZER (DISK SYSTEM)

    MDR report key: 21707516 · Received March 27, 2025

    Report

    Report Number
    1823260-2025-00907
    Event Type
    Malfunction
    Date Received
    March 27, 2025
    Date of Event
    March 10, 2025
    Report Date
    March 27, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630937103
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ESTRADIOL REAGENT LOT NUMBER IS 792358, THE EXPIRATION DATE WAS NOT PROVIDED. A FIELD SERVICE ENGINEER (FSE) DETERMINED THAT THERE WAS A MINOR LEAK AT THE SYRINGE AND THAT IT WAS NOT SEATED PROPERLY ON THE O-RING OF THE GLASS SEAL. THE FSE PLACED THE SYRINGE CORRECTLY AND PERFORMED A PRIME FIVE TIMES. NO LEAKS WERE OBSERVED. TO VERIFY THE INSTRUMENT, A CHECK WAS RUN AND PASSED, AND ALL QC TESTS PASSED. THE INVESTIGATION DETERMINED THAT THE SERVICE ACTION RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF A QUESTIONABLE ESTRADIOL (E2) RESULT FROM THE COBAS E 411 ANALYZER (DISK SYSTEM). THE INITIAL RESULT WAS 18.35 PMOL/L WITH A DATA FLAG, AND THE REPEAT RESULT WAS 11,010 PMOL/L WITH A DATA FLAG. THE CUSTOMER COMPLETED A DILUTION RERUN OF 1:10, AND THE RESULT WAS 10,496 PMOL/L WITH A DATA FLAG. ANOTHER DILUTION RUN WAS COMPLETED OF 1:20, AND THE RESULT WAS 10,609 PMOL/L WITH A DATA FLAG. THE RESULTS FOR THE DILUTED SAMPLES WERE OBTAINED USING AN EXPIRED DILUENT. THE QUESTIONABLE RESULTS WERE REPEATED BECAUSE THE DOCTOR ASKED THE LAB TO RECHECK THE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2472695 COBAS E 411 ANALYZER (DISK SYSTEM) IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS 04015630937103

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Female