BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C 503 ANALYTICAL UNIT

    MDR report key: 19560561 · Received June 18, 2024

    Report

    Report Number
    1823260-2024-01811
    Event Type
    Malfunction
    Date Received
    June 18, 2024
    Date of Event
    June 4, 2024
    Report Date
    June 18, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K191899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CREAJ2 REAGENT LOT NUMBER IS 774950. THE UREAL REAGENT LOT NUMBER IS 790818. THE REAGENT EXPIRATION DATES WERE NOT PROVIDED. THE CUSTOMER CLEARED A PROBE, PERFORMED A PROBE WASH, AND PERFORMED AN AIR PURGE. THE FIELD SERVICE ENGINEER (FSE) FOUND THAT THE SAMPLE PROBE WAS CLOGGED AND CLEARED IT. A PRECISION TEST AND QC WERE PERFORMED SUCCESSFULLY. THE SERVICE MAINTENANCE ACTIONS PERFORMED BY THE FSE RESOLVED THE ISSUE. NO FURTHER ISSUES WERE REPORTED AFTER THE SERVICE VISIT.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE CREJ2 CREATININE JAFFÉ GEN.2 AND UREAL UREA/BUN RESULTS FOR 1 PATIENT PLASMA SAMPLE ON A COBAS C 503 ANALYTICAL UNIT. THE CUSTOMER WAS PROMPTED TO REPEAT THE PATIENT SAMPLE AS THEY WERE RECEIVING ABNORMAL ASPIRATION ALARMS. THE INITIAL CREJ2 RESULT WAS 2.0 MG/DL THE SAMPLE WAS REPEATED ON ANOTHER C503 ANALYZER AND THE RESULT WAS 6.5 MG/DL. THE INITIAL UREAL RESULT WAS 75 MG/DL THE SAMPLE WAS REPEATED ON ANOTHER C503 ANALYZER AND THE RESULT WAS 120 MG/DL. THE REPEAT RESULTS WERE DEEMED CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2338575 COBAS C 503 ANALYTICAL UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown