BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C 503 ANALYTICAL UNIT

    MDR report key: 19655570 · Received July 2, 2024

    Report

    Report Number
    1823260-2024-01916
    Event Type
    Malfunction
    Date Received
    July 2, 2024
    Date of Event
    June 11, 2024
    Report Date
    September 4, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K191899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    GENERAL REAGENT ISSUES COULD BE EXCLUDED AS QC AND CALIBRATION WERE INCONSPICUOUS. THE FIELD SERVICE ENGINEER REPLACED THE SYRINGE UNIT AND RINSE TUBING. HE CHECKED AND ADJUSTED THE SAMPLE PROBE. AFTER THE SERVICE ACTIONS, THE INSTRUMENT PERFORMED AS SPECIFIED. THE INVESTIGATION DETERMINED THAT THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Additional Manufacturer Narrative · 0

    THE GLUCOSE REAGENT LOT NUMBER WAS 747661. THE CREATININE REAGENT LOT NUMBER WAS 772926. THE UREA REAGENT LOT NUMBER WAS 790818. THE EXPIRATION DATES WERE NOT PROVIDED. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FOR TWO PATIENTS FROM THE COBAS C 503 ANALYTICAL UNIT. PATIENT 1 INITIAL GLUCOSE HK GEN.3 RESULT WAS 15.4 MG/DL WITH A DATA FLAG. THE AUTOMATIC REPEAT RESULT WAS 108 MG/DL. PATIENT 2 INITIAL COBAS CREATININE PLUS VER.2 ASSAY RESULT WAS 0.253 MG/DL. THE MANUAL REPEAT RESULT WAS 2.22 MG/DL. THE QUESTIONABLE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. ON 28-JUN-2024, PATIENT 3 INITIAL UREA RESULT WAS 7.15 MG/DL WITH A DATA FLAG. THE REPEAT RESULT WAS 47.7 MG/DL. THE QUESTIONABLE RESULT FOR THIS SAMPLE WAS REPORTED OUTSIDE THE LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801690 COBAS C 503 ANALYTICAL UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown