BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C 503 ANALYTICAL UNIT

    MDR report key: 22140224 · Received June 4, 2025

    Report

    Report Number
    1823260-2025-01717
    Event Type
    Malfunction
    Date Received
    June 4, 2025
    Date of Event
    May 9, 2025
    Report Date
    July 24, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K191899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CREP2 REAGENT LOT NUMBER WAS 853138 WITH AN EXPIRATION DATE OF 31-OCT-2025.

    Additional Manufacturer Narrative · 0

    DAILY CREP2 QC RESULTS WERE UNSTABLE. THE FIELD SERVICE ENGINEER (FSE) REPLACED THE PHOTOMETER LAMP AND CELLS. THE CREP2 QC RESULTS IMPROVED. INSTRUMENT PERFORMANCE TESTING WAS ACCEPTABLE. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    THE INITIAL REPORTER QUESTIONED THE RESULTS FOR MULTIPLE PATIENT SAMPLES TESTED FOR CREATININE PLUS VER.2 (CREP2) ON A COBAS C 503 ANALYTICAL UNIT. A DISCREPANT LOW RESULT WAS PROVIDED FOR 1 PATIENT SAMPLE. THE INITIAL RESULT WAS 48 UMOL/L. ON (B)(6) 2025, THE CUSTOMER REVIEWED PATIENT RESULTS AND NOTICED THAT THE INITIAL RESULT FOR THIS PATIENT WAS DIFFERENT FROM THE RESULTS OF OTHER PATIENT SAMPLES RUN BEFORE AND AFTER THIS SAMPLE; THE RESULTS FOR THE OTHER PATIENT SAMPLES WERE APPROXIMATELY 130-150 UMOL/L. ON (B)(6) 2025, THE CUSTOMER REPEATED THE SAMPLE, AND THE RESULT WAS 123 UMOL/L. THE INITIAL RESULT FOR THE PATIENT WAS AMENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673585 COBAS C 503 ANALYTICAL UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown