BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C (501) MODULE

    MDR report key: 21676013 · Received March 24, 2025

    Report

    Report Number
    1823260-2025-00833
    Event Type
    Malfunction
    Date Received
    March 24, 2025
    Date of Event
    February 28, 2025
    Report Date
    April 15, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630924707
    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 INVESTIGATION DETERMINED THAT THE SERVICE ACTION RESOLVED THE ISSUE.

    Additional Manufacturer Narrative · 0

    THE UREA/BUN LOT NUMBER IS 836564. THE CREATININE JAFFE GEN.2 LOT NUMBER IS 822679. A FIELD SERVICE ENGINEER (FSE) DETERMINED THAT THE SAMPLE LINE ADJUSTMENT WAS OFF AND THE CUSTOMER WAS NOT USING THE MICRO CUP SETTING WHEN SELECTING TESTS. THE FSE ADJUSTED THE SAMPLE LINE AND SHOWED THE CUSTOMER HOW TO MAKE THE MICRO CUP SELECTION. HE INITIALIZED THE ANALYZER WITHOUT ERROR AND COMPARED SAMPLES RAN BETWEEN TWO LINES USING MICRO CUPS. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE UREA/BUN AND CREATININE JAFFE GEN.2 RESULTS FROM THE COBAS 6000 C (501) MODULE. THE INITIAL BUN RESULT WAS A < TEST RESULT, THE REPEAT RESULTS WERE 15 MG/DL AND 72 MG/DL. THE INITIAL CREATININE RESULT WAS A < TEST RESULT, THE REPEAT RESULTS WERE 1.4 MG/DL AND 2.50 MG/DL. THE REPEATED RESULTS WERE FROM ANOTHER C501 AND WERE DEEMED TO BE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489977 COBAS 6000 C (501) MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS 04015630924707

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female