BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 16419412 · Received February 22, 2023

    Report

    Report Number
    1823260-2023-00543
    Event Type
    Malfunction
    Date Received
    February 22, 2023
    Date of Event
    January 25, 2023
    Report Date
    February 22, 2023
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE ENGINEER FOUND THAT THE ISE VACUUM NOZZLE NUT WAS LEFT OFF AND THAT THE KCL LINE WAS PINCHED IN THE LID OF THE ANALYZER. THE ENGINEER PUT THE NUT BACK ON THE ISE VACUUM NOZZLE AND REROUTED KCL LINE TO SPECIFICATION. THE ENGINEER ALSO REPLACED THE ELECTRODES, THE PINCH TUBING, AND THE SIPPER TUBING THAT WAS DUE. THEN RAN GREEN RACK. PERFORMANCE TESTING AND PRECISION STUDIES WERE WITHIN SPECIFICATIONS AND QC WAS SUCCESSFUL. THE SERVICE RESOLVED THE ISSUE BY PUTTING THE NUT BACK ON THE ISE VACUUM NOZZLE AND REROUTING KCL LINES TO SPECIFICATION.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION OF QUESTIONABLE RESULTS FOR 2 PATIENTS' SAMPLE TESTED WITH THE ISE REAGENT ON COBAS C 501 SERIAL NUMBER (B)(4). ON (B)(6) 2023 THE CUSTOMER RAN 2 PATIENTS' SAMPLES (SAMPLES 1 & 2). SAMPLE 1 INITIALLY RESULTED IN NA VALUES OF 127 MMOL/L AND UPON REPEAT AT 1:35 P.M. THE RESULT WAS 128 MMOL/L. SAMPLE 2 INITIALLY RESULTED IN NA VALUES OF 124 MMOL/L AND UPON REPEAT AT 1:32 P.M. THE RESULT WAS 125 MMOL/L. NO INCORRECT RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE SAMPLES WERE REPEATED ON ANOTHER COBAS MODULE AND THE RESULTS THAT DEEMED TO BE CORRECT FOR SAMPLE 1 WAS 135 MMOL/L AND FOR SAMPLE 2 WAS 132 MMOL/L. THE LAST CALIBRATION PERFORMED WAS ON (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1320192 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS C501 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female