BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C (501) MODULE

    MDR report key: 19119355 · Received April 16, 2024

    Report

    Report Number
    1823260-2024-01179
    Event Type
    Malfunction
    Date Received
    April 16, 2024
    Date of Event
    March 17, 2024
    Report Date
    May 6, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    08430215011546
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE ENGINEER FOUND THE ISE ELECTRODES WERE DAMP WITH MOISTURE. HE CLEANED AND CONDITIONED THE ELECTRODES AND BACK-FLUSHED THE PINCH TUBE. HE PERFORMED ISE CHECKS THAT WERE ACCEPTABLE AND THE CUSTOMER RAN CALIBRATION AND QC WITH RESULTS WITHIN THE SPECIFIED RANGES. THE FIELD SERVICE ENGINEER RAN SUCCESSFUL PRECISION. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Additional Manufacturer Narrative · 0

    THE ANALYZER SERIAL NUMBER WAS (B)(6). THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE SODIUM RESULTS FROM THE COBAS 6000 C 501 ANALYZER. SAMPLE (B)(6) INITIAL RESULT WAS 130 MMOL/L AND A REPEAT RESULT WAS 139 MMOL/L FROM THE SAME AND FROM ANOTHER COBAS C501. SAMPLE (B)(6) INITIAL RESULT WAS 144 MMOL/L AND THE REPEAT RESULT WAS 151 MMOL/L FROM THE SAME AND FROM ANOTHER COBAS C501. SAMPLE (B)(6) INITIAL RESULT WAS 129 MMOL/L AND THE REPEAT RESULT WAS 135 MMOL/L FROM THE SAME ANALYZER AND 134 FROM ANOTHER COBAS C501. SAMPLE (B)(6) INITIAL RESULT WAS 124 MMOL/L AND THE REPEAT RESULT WAS 131 MMOL/L FROM THE SAME ANALYZER AND 129 FROM ANOTHER COBAS C501. THE REPEAT RESULTS WERE BELIEVED CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1892410 COBAS 6000 C (501) MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS ASKU 08430215011546
    522009 COBAS 6000 C (501) MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS ASKU 08430215011546

    Patients

    Seq Age Sex Outcome Treatment
    1 8 MO Male