BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C 503 ANALYTICAL UNIT

    MDR report key: 19690387 · Received July 8, 2024

    Report

    Report Number
    1823260-2024-01955
    Event Type
    Malfunction
    Date Received
    July 8, 2024
    Date of Event
    June 18, 2024
    Report Date
    September 19, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K191899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE ENGINEER INSPECTED THE ANALYZER AND FOUND LEAKAGE AND CRYSTALLIZATION OF SODIUM HYDROXIDE DETERGENT (NAOHD) IN THE CHECK VALVE. HE THEN CLEANED AND TIGHTENED THE VALVE. HE ALSO REPLACED THE TEFLON RISING TUBE, BLEACHED THE TUBE IN CONTACT WITH THE NAOHD, AND ADJUSTED THE RINSE LEVELS. THE INVESTIGATION DETERMINED THE EVENT WAS RELATED TO A MAINTENANCE/ADJUSTMENT ISSUE. AFTER SERVICE, NO FURTHER ISSUES WERE REPORTED BY THE CUSTOMER. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Additional Manufacturer Narrative · 0

    THE REAGENT LOT NUMBER IS 801069. THE EXPIRATION DATE WAS NOT PROVIDED. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THE INITIAL REPORTER RECEIVED QUESTIONABLE COBAS CREATININE PLUS VER.2 ASSAY RESULTS FROM TWO PATIENT SAMPLES TESTED ON THE COBAS C 503 ANALYTICAL UNIT. ON 18-JUN-2024: SAMPLE 1 THE INITIAL RESULT FROM THE ANALYZER WAS 159 UMOL/L. THE FIRST REPEAT RESULT FROM A SECOND COBAS ANALYZER WAS 49 UMOL/L. THE SECOND REPEAT RESULT FROM THE ANALYZER WAS 50.7 UMOL/L. ON 21-JUN-2024: SAMPLE 2 THE INITIAL RESULT WAS 151 UMOL/L. THIS RESULT WAS DIFFERENT FROM THE PREVIOUS RESULT. THE REPEAT RESULT WAS 66.2 UMOL/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    980040 COBAS C 503 ANALYTICAL UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown