BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C 503 ANALYTICAL UNIT

    MDR report key: 23057356 · Received September 15, 2025

    Report

    Report Number
    1823260-2025-02883
    Event Type
    Malfunction
    Date Received
    September 15, 2025
    Date of Event
    August 5, 2025
    Report Date
    September 15, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K191899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TOTAL PROTEIN GEN.2: THE REAGENT LOT NUMBER IS 883217. THE EXPIRATION DATE WAS REQUESTED BUT NOT PROVIDED. THE CREATININE REAGENT LOT NUMBER AND EXPIRATION DATE WERE REQUESTED BUT NOT PROVIDED. THE INVESTIGATION INCLUDED A REVIEW OF THE DATA SET PROVIDED BY THE CUSTOMER: THE PATIENT'S ASSAY RESULTS HAD SEVERAL ALARMS. THE REACTION KINETICS MONITORS INDICATE THAT NO OR LESS SAMPLE WAS PIPETTED. THE ALARM TRACE SHOWED MULTIPLE ABNORMAL ASPIRATION ALARMS. THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE ANALYZER AND CONFIRMED THAT THE PROBES, RINSE LEVELS, ULTRASONIC MIXER, SONIC WASH STATION, AND GEAR PUMP HEAD (GPH) PRESSURE WERE FUNCTIONING ACCORDING TO SPECIFICATIONS. THE SPECIFIC CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    THE INITIAL REPORTER RECEIVED QUESTIONABLE TOTAL PROTEIN GEN.2 AND CREATININE RESULTS FROM MULTIPLE PATIENT SAMPLES TESTED ON THE COBAS C 503 ANALYTICAL UNIT. THE REPORTER PROVIDED THE FOLLOWING EXAMPLES OF DISCREPANT RESULTS: ON (B)(6) 2025: PATIENT SAMPLE 1 TOTAL PROTEIN THE INITIAL RESULT WAS 2.77 G/L WITH A DATA FLAG OR 2.8 G/L. THE REPEAT RESULT WAS 60.6 G/L. ON (B)(6) 2025: PATIENT SAMPLE 2 TOTAL PROTEIN THE INITIAL RESULT WAS 3.8 G/L. THE REPEAT RESULT WAS 75 G/L. ON (B)(6) 2025: PATIENT SAMPLE 3 TOTAL PROTEIN THE INITIAL RESULT WAS 60.7 G/L. THE REPEAT RESULT WAS <2 G/L. ON (B)(6) 2025: PATIENT SAMPLE 4 TOTAL PROTEIN THE INITIAL RESULT WAS 63.8 G/L. THE REPEAT RESULT WAS 69 G/L. PATIENT SAMPLE 5 TOTAL PROTEIN THE INITIAL RESULT WAS 34 G/L. THE REPEAT RESULT WAS 64.1 G/L. CREATININE THE INITIAL RESULT WAS 77 UMOL/L. THE REPEAT RESULT WAS 143 UMOL/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1475268 COBAS C 503 ANALYTICAL UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown