BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E 411 ANALYZER (DISK SYSTEM)

    MDR report key: 20824439 · Received December 2, 2024

    Report

    Report Number
    1823260-2024-03492
    Event Type
    Malfunction
    Date Received
    December 2, 2024
    Date of Event
    November 12, 2024
    Report Date
    January 9, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630937103
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CALIBRATION AND CONTROLS WERE ACCEPTABLE. THERE WAS NO INDICATION OF A REAGENT PERFORMANCE ISSUE. UPON REVIEW OF THE ALARM TRACE, NO RELEVANT ALARMS WERE OBSERVED. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Additional Manufacturer Narrative · 0

    THE ESTRADIOL REAGENT LOT NUMBER WAS 792358. THE REAGENT EXPIRATION DATE WAS REQUESTED, BUT NOT PROVIDED. THE FIELD SERVICE ENGINEER DETERMINED THE SIPPER PROBE WAS OUT OF ADJUSTMENT. THE SIPPER PROBE WAS ADJUSTED. THE SYRINGE SEALS WERE REPLACED AND THE GLASS BARRELS WERE CLEANED. THE PROBES WERE PRIMED. THE MIXER AND SYSTEM VOLUME WERE CHECKED. THE PHOTOMULTIPLIER TUBE HIGH VOLTAGE ADJUSTMENT AND BLANK CELL CALIBRATION WERE COMPLETED SUCCESSFULLY. MEASURING CELL PREPARATION MAINTENANCE WAS PERFORMED. PERFORMANCE TESTING WAS RUN AND RECOVERED WITHIN SPECIFICATIONS. THE CUSTOMER RAN PATIENT SAMPLES IN DUPLICATE TO MONITOR PRECISION. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS ESTRADIOL III ON A COBAS E 411 ANALYZER. THE SAMPLE INITIALLY RESULTED IN AN ESTRADIOL VALUE OF < 5.00 PG/ML WITH A DATA FLAG. THE RESULT WAS QUESTIONED BY THE DOCTOR. THE SAMPLE WAS REPEATED TWICE, RESULTING IN ESTRADIOL VALUES OF 1502 PG/ML AND 1482 PG/ML. THE 1502 PG/ML VALUE WAS DEEMED CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97228 COBAS E 411 ANALYZER (DISK SYSTEM) IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS 04015630937103

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female