BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C 311 ANALYZER

    MDR report key: 19842499 · Received July 26, 2024

    Report

    Report Number
    1823260-2024-02181
    Event Type
    Malfunction
    Date Received
    July 26, 2024
    Date of Event
    July 4, 2024
    Report Date
    October 4, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630925551
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE C311 ANALYZER SERIAL NUMBER WAS (B)(6). THE COMPETITOR METHOD WAS WIENER.

    Additional Manufacturer Narrative · 0

    THE ASTL REAGENT LOT NUMBER WAS 73051501 WITH AN EXPIRATION DATE OF 31-AUG-2024. CALIBRATION AND QC WERE ACCEPTABLE. THE FIELD SERVICE REPRESENTATIVE (FSR) CHECKED THE INSTRUMENT, REPLACED THE ULTRASONIC MIXER, AND ADJUSTED THE FREQUENCY. THE CUSTOMER HAS HAD NO FURTHER ISSUES SINCE THE SERVICE VISIT. BASED ON THE INFORMATION PROVIDED, THE SPECIFIC CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ASPARTATE AMINOTRANSFERASE ACC. TO IFCC WITHOUT PYRIDOXAL PHOSPHATE ACTIVATION (ASTL) ON A COBAS C 311 ANALYZER. THE INITIAL RESULT FROM THE C311 ANALYZER WAS 59 U/L. ON (B)(6) 2024 THE SAMPLE WAS SENT TO AN EXTERNAL LABORATORY WHERE THE RESULT FROM A COMPETITOR METHOD WAS 89 U/L. THE QUESTIONABLE RESULT WAS NOT GIVEN TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    922844 COBAS C 311 ANALYZER CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS 73051501 04015630925551

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown