BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C 503 ANALYTICAL UNIT

    MDR report key: 24619727 · Received March 17, 2026

    Report

    Report Number
    1823260-2026-00945
    Event Type
    Malfunction
    Date Received
    March 17, 2026
    Date of Event
    October 1, 2025
    Report Date
    May 19, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K191899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE C503 ANALYZER SERIAL NUMBER WAS (B)(6). THERE WERE MULTIPLE "ABNORMAL CELL BLANK" ALARMS; THESE ALARMS INDICATE DIRT IN THE CELL. THE FIELD SERVICE ENGINEER (FSE) PERFORMED AN INSTRUMENT CHECK, WHICH SUGGESTED ISSUES WITH THE ULTRASONIC MIXER (USM), SAMPLE PIPETTING, AND CELL RINSE. THE USM, REAGENT PROBES, AND A SAMPLE PROBE WERE ADJUSTED. THE CELL RINSE VOLUME, PRIME WASH SOLUTION FLOW PATH, AND MECHANISMS WERE CHECKED. THE INSTRUMENT CHECK WAS REPEATED WITH IMPROVED RESULTS. THE CUSTOMER PERFORMED QC. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER HAS CHANGED THE CUT-OFF FOR CANNABINOIDS II FROM 20 UG/L TO 25 G/L. UPON MAKING THIS CHANGE, THE CUSTOMER HAS SEEN A DECREASE IN THE NUMBER OF QUESTIONABLE POSITIVE RESULTS. THE CUSTOMER PROVIDED THE FOLLOWING INFORMATION: (B)(6) 2026, 19 QUESTIONABLE POSITIVE RESULTS OUT OF 100 SAMPLES. (B)(6) 2026, 18 QUESTIONABLE POSITIVE RESULTS OUT OF 116 SAMPLES. (B)(6) 2026, 10 QUESTIONABLE POSITIVE RESULTS OUT OF 76 SAMPLES. NO SPECIFIC COMPARISON RESULTS WERE PROVIDED.

    Description of Event or Problem · 0

    THE INITIAL REPORTER QUESTIONED POSITIVE RESULTS FOR MULTIPLE PATIENT URINE SAMPLES TESTED FOR ONLINE DAT CANNABINOIDS II (CANNABINOIDS II) ON A COBAS C 503 ANALYTICAL UNIT BETWEEN (B)(6) 2025. THE FOLLOWING ARE EXAMPLES OF DISCREPANT RESULTS FOR 2 PATIENT SAMPLES. PATIENT 1 RESULT FROM THE C503 ANALYZER WAS 21.7 NG/ML. THE SAMPLE WAS TESTED BY LIQUID CHROMATOGRAPHY-MASS SPECTROMETRY (LCMS), AND THE RESULT WAS 6.02 NG/ML. PATIENT 2 RESULT FROM THE C503 ANALYZER WAS 82.5 NG/ML. THE SAMPLE WAS TESTED BY LIQUID CHROMATOGRAPHY-MASS SPECTROMETRY (LCMS), AND THE RESULT WAS 0.3 NG/ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    516522 COBAS C 503 ANALYTICAL UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1