BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 21797681 · Received April 8, 2025

    Report

    Report Number
    1823260-2025-01065
    Event Type
    Malfunction
    Date Received
    April 8, 2025
    Date of Event
    March 16, 2025
    Report Date
    April 23, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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

    CALIBRATION WAS LAST PERFORMED ON (B)(6) 2025 WITH ACCEPTABLE RESULTS. THE FIELD SERVICE ENGINEER (FSE) FOUND A BLOCKAGE IN THE SIPPER TUBING AND THE SIPPER NEEDED ADJUSTING. THE FSE CLEARED THE SIPPER TUBING AND ADJUSTED THE SIPPER. QC WAS ACCEPTABLE. OPERATIONAL AND MECHANICAL CHECKS PASSED. THE INVESTIGATION DETERMINED THAT THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THE INITIAL REPORTER COMPLAINED OF QC ISSUES WITH ELECSYS TROPONIN T GEN 5 STAT (TROPONIN T STAT) ON A COBAS 6000 E601 MODULE. DUE TO QC ISSUES, THE CUSTOMER REPEATED PATIENT SAMPLES THAT HAD BEEN RUN AND REPORTED OUTSIDE OF THE LABORATORY. CORRECTED REPORTS WERE ISSUED FOR 9 PATIENT SAMPLES. AN EXAMPLE OF DISCREPANT RESULTS WAS PROVIDED FOR 1 PATIENT SAMPLE. THE INITIAL RESULT WAS 79.87 NG/L. THE REPEAT RESULT WAS 120.20 NG/L. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754476 COBAS 6000 E601 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E601

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown