BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C 503 ANALYTICAL UNIT

    MDR report key: 20462981 · Received October 16, 2024

    Report

    Report Number
    1823260-2024-02989
    Event Type
    Malfunction
    Date Received
    October 16, 2024
    Date of Event
    September 22, 2024
    Report Date
    October 16, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K191899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CA2 REAGENT LOT NUMBER WAS 803015 WITH AN EXPIRATION DATE OF 31-AUG-2025. THE FIELD SERVICE ENGINEER (FSE) FOUND THAT THE EVENT WAS CAUSED BY THE RINSE MECHANISM DISPENSING TOO MUCH CLEANER INTO THE CUVETTES CAUSING SPILLAGE INTO OTHER CUVETTES. HE ADJUSTED THE RINSE MECHANISM LEVELS. PRECISION STUDIES WERE PERFORMED AND THEY WERE WITHIN SPECIFICATIONS. THE CUSTOMER PERFORMED CALIBRATION AND QC AND THEY WERE SUCCESSFUL. THE SERVICE ACTIONS (ADJUSTING THE RINSE MECHANISM LEVELS) RESOLVED THE ISSUE. NO FURTHER ISSUES WERE REPORTED AFTERWARD.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION ABOUT DISCREPANT LOW RESULTS FOR 1 PATIENT PLASMA SAMPLE TESTED WITH CALCIUM GEN.2 (CA2) ASSAY ON A COBAS C503 ANALYTICAL UNIT WHEN COMPARED TO A DIFFERENT COBAS C503 ANALYTICAL UNIT. INITIAL RESULT: 6.2 MG/DL. THE PHYSICIAN QUESTIONED THE INITIAL RESULT AND REQUESTED A REPEAT. THE SAMPLE WAS THEN REPEATED. REPEAT RESULT: 8.8 MG/DL. THE REPEAT RESULT WAS DEEMED TO BE CORRECT. REPORTEDLY, AN AMENDED REPORT WITH THE CORRECT RESULT WAS ISSUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1322756 COBAS C 503 ANALYTICAL UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female