BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C 503 ANALYTICAL UNIT

    MDR report key: 25275977 · Received May 26, 2026

    Report

    Report Number
    1823260-2026-02059
    Event Type
    Malfunction
    Date Received
    May 26, 2026
    Date of Event
    April 24, 2026
    Report Date
    May 26, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K191899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CALCIUM REAGENT LOT NUMBER IS 894309. THE MAGNESIUM REAGENT LOT NUMBER IS 922940. THE EXPIRATION DATES WERE NOT PROVIDED. THE ALARM TRACE SHOWED "SAMPLE FOAM DETECTION" AND "ABNORMAL ASPIRATION" ALARMS. THE FIELD SERVICE REPRESENTATIVE PERFORMED CLEANINGS, FLUSHED THE VACUUM AND TUBING/NOZZLES, PERFORMED ADJUSTMENTS AND INSPECTIONS, REPLACED A BENT PROBE, AND PERFORMED CHECKS. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE MAGNESIUM GEN.2 AND CALCIUM GEN.2 RESULTS FOR 1 PATIENT ON A COBAS C 503 ANALYTICAL UNIT. SAMPLE 1: THE INITIAL MAGNESIUM RESULT WAS 1.93 MMOL/L, AND THE REPEATED RESULT WAS 0.83 MMOL/L. SAMPLE 2: ON (B)(6)2026, THE INITIAL CA RESULT WAS 1.49 MMOL/L, AND ON (B)(6) 2026, THE REPEATED RESULT WAS 2.31 MMOL/L. SAMPLE 3: THIS SAMPLE WAS OBTAINED AT THE SAME TIME AS SAMPLE 2. THE INITIAL RESULT WAS 2.37 MMOL/L, AND THE REPEATED RESULT WAS 2.33 MMOL/L. THE SAMPLES WERE REPEATED BECAUSE THE PHYSICIAN QUESTIONED THE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351162 COBAS C 503 ANALYTICAL UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1