BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E 411 ANALYZER (RACK SYSTEM)

    MDR report key: 20689237 · Received November 14, 2024

    Report

    Report Number
    1823260-2024-03320
    Event Type
    Malfunction
    Date Received
    November 14, 2024
    Date of Event
    November 4, 2024
    Report Date
    November 14, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630924721
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FERRITIN REAGENT LOT NUMBER WAS 821406 WITH AN EXPIRATION DATE OF 31-JAN-2026. THE FIELD SERVICE ENGINEER (FSE) REPLACED THE SAMPLE/REAGENT PROBE TUBING AND THE SEAL, CLEANED THE SAMPLE/REAGENT PROBE, AND CLEANED THE MIXER RINSE STATION AND THE WATER TANK. THE INVESTIGATION DETERMINED THE EVENT WAS DUE TO A SAMPLE/REAGENT PIPETTING ISSUE. THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THE INITIAL REPORTER COMPLAINED OF A DISCREPANT LOW RESULT FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS FERRITIN (FERRITIN) ON A COBAS E 411 ANALYZER (RACK SYSTEM). THE INITIAL RESULT WAS 2.83 UG/L. THE REPEAT RESULT WAS 71.92 UG/L. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1297637 COBAS E 411 ANALYZER (RACK SYSTEM) IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS 04015630924721

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown