BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C 503 ANALYTICAL UNIT

    MDR report key: 21676145 · Received March 24, 2025

    Report

    Report Number
    1823260-2025-00840
    Event Type
    Malfunction
    Date Received
    March 24, 2025
    Date of Event
    March 13, 2025
    Report Date
    March 24, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    07613336121528
    PMA / PMN Number
    K951595
    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 REAGENT LOT NUMBER WAS 851302. THE EXPIRATION DATE WAS NOT PROVIDED. THE QUALITY CONTROL RESULTS WERE ACCEPTABLE AT THE BEGINNING AND AT THE END OF THE RUN. THE FIELD SERVICE ENGINEER CHECKED THE WASH STATION, THE CELL RINSE LEVEL, AND THE SAMPLE PROBE. WHICH WERE ACCEPTABLE. HE PERFORMED PREVENTIVE MAINTENANCE. THE ANALYZER ALARM TRACES SHOWED FREQUENT "ABNORMAL ASPIRATION ERRORS" FOR THE SAMPLE PROBE.T HIS IS AN INDICATION FOR PREANALYTIC ISSUES. CORRECT PRE-ANALYTIC SAMPLE HANDLING IS WITHIN THE CUSTOMER'S RESPONSIBILITY. THE INVESTIGATION DID NOT IDENTIFY A SPECIFIC ROOT CAUSE.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE TOTAL PROTEIN GEN.2 RESULTS FROM THE COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 105 G/L. THE REPEAT RESULT WAS 73.5 G/L. THE REPEAT RESULT USING ANOTHER COBAS C503 ANALYZER WAS 73 G/L. THE QUESTIONABLE RESULT WAS NOT REPORTED TO THE PHYSICIAN OR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739039 COBAS C 503 ANALYTICAL UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS 07613336121528

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown