BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 22095029 · Received May 28, 2025

    Report

    Report Number
    1823260-2025-01626
    Event Type
    Malfunction
    Date Received
    May 28, 2025
    Date of Event
    May 20, 2025
    Report Date
    May 28, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630924714
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FT3 REAGENT LOT NUMBER IS 801917 AND THE FT4 REAGENT LOT NUMBER IS 816060. THE REAGENT EXPIRATION DATES WERE REQUESTED, BUT NOT PROVIDED. THE FIELD SERVICE ENGINEER FOUND DAMAGED PINCH VALVE TUBING. THE PINCH VALVE TUBING AND MEASURING CELLS WERE REPLACED. IT WAS IDENTIFIED THAT MEASURING CELL AND PINCH VALVE PREVENTIVE MAINTENANCE WERE OVERDUE. THE INSTRUMENT WAS RUNNING BACK WITHIN SPECIFICATIONS AFTER THESE ACTIONS. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS FT3 III AND ELECSYS FT4 IV ON A COBAS 6000 E601 MODULE. THE SAMPLE INITIALLY RESULTED IN A FT3 VALUE OF 6.43 PG/ML AND WHEN REPEATED ON A SECOND ANALYZER, IT RESULTED IN A VALUE OF 1.59 PG/ML. THE SAMPLE INITIALLY RESULTED IN A FT4 VALUE OF > 77.69 NG/L WITH A DATA FLAG AND WHEN REPEATED ON A SECOND ANALYZER, IT RESULTED IN A VALUE OF 17.94 NG/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714261 COBAS 6000 E601 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E601 04015630924714

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown