BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 21813295 · Received April 10, 2025

    Report

    Report Number
    1823260-2025-01090
    Event Type
    Malfunction
    Date Received
    April 10, 2025
    Date of Event
    March 17, 2025
    Report Date
    April 10, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REAGENT LOT NUMBER IS 802253. THE EXPIRATION DATE WAS NOT PROVIDED. THE CALIBRATION AND QC WERE ACCEPTABLE. A GENERAL REAGENT ISSUE WAS EXCLUDED. THE FIELD SERVICE REPRESENTATIVE COMPLETED PREVENTATIVE MAINTENANCE AND REPLACED THE MEASURING CELL. HE PERFORMED CHECKS AND TESTS WITH ACCEPTABLE RESULTS. AFTER SERVICE, NO ISSUES WERE REPORTED BY THE CUSTOMER. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TROPONIN T GEN 5 STAT RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 6000 E601 MODULE. THE INITIAL RESULT WAS <6 NG/L WITH A DATA FLAG. THE RESULT FAILED A DELTA CHECK, BUT THE RESULT WAS REPORTED OUTSIDE THE LABORATORY. DUE TO THE FAILED DELTA CHECK, THE SAMPLE WAS REPEATED ON ANOTHER MODULE AND THE RESULT WAS 352 NG/L. THE REPEATED RESULT WAS BELIEVED TO BE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1664710 COBAS 6000 E601 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E601

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown