BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C 503 ANALYTICAL UNIT

    MDR report key: 22009852 · Received May 13, 2025

    Report

    Report Number
    1823260-2025-01477
    Event Type
    Malfunction
    Date Received
    May 13, 2025
    Date of Event
    April 21, 2025
    Report Date
    May 13, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K191899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REAGENT LOT NUMBER WAS 823706. THE EXPIRATION DATE WAS NOT PROVIDED. THE FIELDS SERVICE ENGINEER ADJUSTED THE REACTION WASH CUVETTES, DECONTAMINATED AND ADJUSTED THE SAMPLE AND REAGENT PIPETTING SYSTEM, AND REPAIRED THE SYRINGES. THE CUSTOMER PERFORMED THE QC TESTING AND CALIBRATION, WHICH WERE SUCCESSFUL. A GENERAL LOT-RELATED ISSUE CAN BE EXCLUDED, SINCE CALIBRATION AND QC DATA ARE ACCEPTABLE. THE INVESTIGATION WAS UNABLE TO DETERMINE A SPECIFIC ROOT CAUSE. THE EVENT WAS CONSISTENT WITH PRE-ANALYTICAL HANDLING ISSUES AT THE CUSTOMER SITE. CORRECT PRE-ANALYTIC SAMPLE HANDLING IS WITHIN THE CUSTOMER'S RESPONSIBILITY.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE PHOSPHATE (INORGANIC) VER.2 RESULTS FROM THE COBAS C 503 ANALYTICAL UNIT. SAMPLE 1 INITIAL RESULT WAS 11.5 MG/DL, AND THE REPEAT RESULT WAS 4.63 MG/DL. SAMPLE 2 INITIAL RESULT WAS 15.4 MG/D,L AND THE REPEAT RESULT WAS 2.40 MG/DL. THE QUESTIONABLE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2370814 COBAS C 503 ANALYTICAL UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown