BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C 503 ANALYTICAL UNIT

    MDR report key: 24039078 · Received January 12, 2026

    Report

    Report Number
    1823260-2026-00143
    Event Type
    Malfunction
    Date Received
    January 12, 2026
    Date of Event
    December 22, 2025
    Report Date
    January 12, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K191899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CREATININE REAGENT LOT NUMBER IS 900144 AND THE GLUCOSE REAGENT LOT NUMBER IS 882312. CALIBRATION WAS LAST PERFORMED ON THE DAY OF THE EVENT. THE QC RECOVERY DATA PROVIDED WAS ACCEPTABLE. THE ALARM TRACE SHOWED AN ABNORMAL ASPIRATION ALARM. THE FIELD SERVICE ENGINEER (FSE) FOUND BUILD UP ON THE SAMPLE PROBE. THE FSE ADJUSTED THE WATER PRESSURE, ADJUSTED THE GEAR PUMP HEAD, INCREASED THE CELL RINSE VOLUME, ADJUSTED THE SAMPLE PROBE RINSE STATION FLOW, AND REPLACED THE SAMPLE PROBE. THE FSE PERFORMED MECHANISM CHECKS AND PRECISION TESTING SUCCESSFULLY. THE CUSTOMER PERFORMED QC SUCCESSFULLY. THE SERVICE MAINTENANCE ACTIONS PERFORMED BY THE FSE RESOLVED THE ISSUE. NO FURTHER ISSUES WERE REPORTED AFTER THE SERVICE VISIT.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE GLUCOSE HK GEN.3 AND CREATININE PLUS VER.2 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS C 503 ANALYTICAL UNIT. THE CUSTOMER WAS PROMPTED TO REPEAT THE SAMPLE DUE TO THE ACCOMPANYING DATA FLAGS. THE INITIAL GLUCOSE RESULT WAS 5.04 MG/DL WITH FLAG AND THE INITIAL CREATININE RESULT WAS 0.6 MG/DL ACCOMPANIED BY A FLAG INDICATING THE VALUE IS BELOW THE LINEARITY/MEASURING RANGE OF THE ASSAY. THE SAMPLE WAS REPEATED ON ANOTHER ANALYZER AND THE GLUCOSE RESULT WAS 96.2 MG/DL AND THE CREATININE RESULT WAS 66 MG/DL. THE REPEAT RESULTS WERE DEEMED CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93163 COBAS C 503 ANALYTICAL UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown