BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C 503 ANALYTICAL UNIT

    MDR report key: 22435552 · Received July 8, 2025

    Report

    Report Number
    1823260-2025-02080
    Event Type
    Malfunction
    Date Received
    July 8, 2025
    Date of Event
    June 4, 2025
    Report Date
    October 30, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K191899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SERIAL NUMBER OF (B)(6) WAS PROVIDED FOR ONE OF THE C 503 SYSTEMS, BUT IT IS NOT KNOWN IF THIS WAS THE SERIAL NUMBER FOR THE FIRST OR THE SECOND ANALYZER. THE SERIAL NUMBER OF THE OTHER ANALYZER WAS NOT PROVIDED. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    A REVIEW OF ALARM TRACE DATA SHOWED A HIGH FREQUENCY OF SAMPLE RELATED ALARMS. FROM 01-JUL-2025 TO 22-SEP-2025, THERE WERE A TOTAL OF 842 ABNORMAL ASPIRATION ALARMS. CALIBRATION AND CONTROL DATA WERE ACCEPTABLE. THERE WAS NO INDICATION OF A GENERAL REAGENT ISSUE. THE INVESTIGATION DETERMINED THE ISSUE IS CONSISTENT WITH INSUFFICIENT PRE-ANALYTIC SAMPLE HANDLING IN COMBINATION WITH AN ISSUE WITH THE INSTRUMENT'S CELL RINSE FUNCTIONALITY. MEDWATCH FIELDS D1, D2, D4, G1, AND G4 HAVE BEEN UPDATED.

    Additional Manufacturer Narrative · 0

    THE TRIGLYCERIDES REAGENT LOT NUMBER 851627 WAS USED FOR THE FIRST TWO SAMPLES. THE TRIGLYCERIDES REAGENT LOT NUMBER ON 16-JUN-2025 WAS 861340. THE FIRST SAMPLE WAS TESTED ON 04-JUN-2025. THE SECOND SAMPLE WAS TESTED ON 10-JUN-2025. THE THIRD SAMPLE WAS TESTED ON 16-JUN-2025. MEDWATCH FIELDS B4 AND D4 HAVE BEEN UPDATED.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR THREE PATIENT SAMPLES TESTED WITH THE TRIGLYCERIDES ASSAY ON TWO COBAS C 503 ANALYTICAL UNIT ANALYZERS. THE FIRST SAMPLE INITIALLY RESULTED IN A TRIGLYCERIDES VALUE OF 395 MG/DL WHEN TESTED ON THE FIRST C 503 SYSTEM. WHEN REPEATED ON THE SECOND C 503 SYSTEM, IT RESULTED IN A VALUE OF 288 MG/DL. THE SECOND SAMPLE INITIALLY RESULTED IN A TRIGLYCERIDES VALUE OF 350 MG/DL AND IT REPEATED AS 105 MG/DL WHEN TESTED ON THE SECOND C 503 SYSTEM. THE THIRD SAMPLE INITIALLY RESULTED IN A TRIGLYCERIDES VALUE OF 307 MG/DL AND IT REPEATED AS 80.7 WHEN TESTED ON THE SECOND C 503 SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387525 COBAS C 503 ANALYTICAL UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS 851627, 861340

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown