BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 22201494 · Received June 13, 2025

    Report

    Report Number
    1823260-2025-01819
    Event Type
    Malfunction
    Date Received
    June 13, 2025
    Date of Event
    May 16, 2025
    Report Date
    June 26, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630924714
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THE EVENT WAS DUE TO MISSED AND/OR OVERDUE MAINTENANCE.

    Additional Manufacturer Narrative · 0

    THE CORTISOL II REAGENT LOT NUMBER WAS 822767 WITH AN EXPIRATION DATE OF 01-OCT-2025. THE CUSTOMER MENTIONED THAT THEY HAD SOME LIQUID LEVEL DETECTION (LLD) ALARMS LATELY, AND A BIT OF RUST ON THE MICROBEAD MIXER. THE PREVENTIVE MAINTENANCE WAS LAST PERFORMED ON 14-APR-2025, AND IT WAS WITHIN SPECIFICATIONS. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT'S SAMPLES TESTED WITH ELECSYS CORTISOL G2 (CORTISOL II) ASSAY ON A COBAS 6000 E601 MODULE. SAMPLE 1: INITIAL RESULT: 0.054 UG/DL (ACCOMPANIED BY A DATA FLAG). 1ST REPEAT RESULT: 63.44 UG/DL (ACCOMPANIED BY A DATA FLAG). ON (B)(6) 2025: SAMPLE 1: 2ND REPEAT RESULT: 104.7 UG/DL (TESTED USING A DILUTION FACTOR OF 1:10). A NEW SAMPLE WAS DRAWN FROM THE PATIENT AND TESTED, RESULTING IN A CORTISOL II VALUE OF 34.3 UG/DL. THE RESULT OF 34.3 UG/DL WAS DEEMED TO BE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376887 COBAS 6000 E601 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E601 04015630924714

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown