BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 21560586 · Received March 10, 2025

    Report

    Report Number
    1823260-2025-00682
    Event Type
    Malfunction
    Date Received
    March 10, 2025
    Date of Event
    February 11, 2025
    Report Date
    April 4, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE TROPONIN T STAT REAGENT LOT NUMBER WAS 802253 WITH AN EXPIRATION DATE OF 31-OCT-2025.

    Additional Manufacturer Narrative · 0

    QC WAS ACCEPTABLE. THERE IS NO INDICATION OF A REAGENT PERFORMANCE ISSUE. NO ISSUES WERE IDENTIFIED DURING A REVIEW OF THE ALARM TRACE DATA. THE FIELD SERVICE ENGINEER (FSE) FOUND THE WATER PRESSURE WAS TOO HIGH. THE FSE ADJUSTED THE WATER PRESSURE AND THE GEAR PUMP PRESSURE. THE SERVICE MAINTENANCE ACTIONS RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THE INITIAL REPORTER QUESTIONED HIGH RESULTS FOR 2 PATIENT SAMPLES TESTED FOR ELECSYS TROPONIN T GEN 5 STAT (TROPONIN T STAT) ON A COBAS 6000 E601 MODULE. DISCREPANT RESULTS WERE PROVIDED FOR 1 PATIENT SAMPLE. THE INITIAL RESULT WAS 48.07 PG/ML. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY WHERE THE DOCTOR QUESTIONED IT. THE REPEAT RESULT FROM A DIFFERENT E601 MODULE WAS 18.10 PG/ML. THIS RESULT WAS BELIEVED TO BE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2144486 COBAS 6000 E601 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E601

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown