BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C (501) MODULE

    MDR report key: 12210074 · Received July 22, 2021

    Report

    Report Number
    1823260-2021-02125
    Event Type
    Malfunction
    Date Received
    July 22, 2021
    Date of Event
    July 6, 2021
    Report Date
    November 10, 2021
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630924707
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Additional Manufacturer Narrative · 1

    WASHING MAINTENANCE WAS PERFORMED ON THE ANALYZER. CALIBRATION WAS PERFORMED AND WAS SUCCESSFUL. AN ISE CHECK WAS PERFORMED AND WAS ACCEPTABLE, WITH NO ALARMS. CONTROLS WERE RUN SEVERAL TIMES AND SHOWED POOR PRECISION, SOME CONTROL RUNS WERE OUTSIDE OF RANGE. PRECISION STUDIES WERE PERFORMED AND IMPRECISION WITH NA WAS OBSERVED. THE FIELD SERVICE ENGINEER REPLACED THE RINSE TUBING. PRECISION STUDIES PERFORMED AFTER THE TUBING REPLACEMENT SHOWED BETTER PRECISION.

    Description of Event or Problem · 1

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ISE INDIRECT NA FOR GEN.2 ON A COBAS 6000 C (501) MODULE. NO INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED IN A NA VALUE OF 179 MMOL/L. THE SAMPLE WAS REPEATED ON A SECOND C 501 ANALYZER, RESULTING IN A VALUE OF 139 MMOL/L. THE NA ELECTRODE LOT NUMBER WAS K96_2021, WITH AN EXPIRATION DATE OF 22-DEC-2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1111356 COBAS 6000 C (501) MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS C501 NA 04015630924707

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown