BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C 503 ANALYTICAL UNIT

    MDR report key: 23478952 · Received November 5, 2025

    Report

    Report Number
    1823260-2025-04515
    Event Type
    Malfunction
    Date Received
    November 5, 2025
    Date of Event
    October 15, 2025
    Report Date
    December 22, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K191899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION WAS UNABLE TO DETERMINE A DIRECT ROOT CAUSE. A REAGENT ISSUE WAS EXCLUDED AS THERE WERE NO ADDITIONAL EVENTS, AND THE CORRECT REPEAT RESULT WAS OBTAINED WITH THE SAME REAGENT. A FIELD SERVICE ENGINEER (FSE) DETERMINED THAT THE TEST AND MODULE WERE RUNNING WITHIN SPECIFICATIONS.

    Additional Manufacturer Narrative · 0

    THE ALBUMIN GEN.2 REAGENT LOT NUMBER IS 881109, AND THE EXPIRATION DATE WAS NOT PROVIDED. THE TINA-QUANT ALBUMIN GEN. REAGENT LOT NUMBER IS 883906, AND THE EXPIRATION DATE WAS NOT PROVIDED. IT WAS REPORTED THAT THE SAMPLE WAS HEMOLYTIC. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF A QUESTIONABLE ALBUMIN GEN.2 RESULT FROM THE COBAS C 503 ANALYTICAL UNIT FOR ONE PATIENT. THE INITIAL ALBUMIN GEN.2 RESULT WAS 0.356 G/DL. THE SAMPLE WAS REPEATED AFTER AN INTERNAL LABORATORY EVALUATION, AND THEY THEN MEASURED WITH TINA-QUANT ALBUMIN GEN. (ALBT2). THE RESULT FOR ALBT2 WAS 3.56 G/DL. THE ALBUMIN GEN.2 REPEAT RESULT WAS NOT PROVIDED. THE ALBT2 RESULT WAS CONSIDERED TO BE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2636534 COBAS C 503 ANALYTICAL UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown