BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C 503 ANALYTICAL UNIT

    MDR report key: 24401110 · Received February 20, 2026

    Report

    Report Number
    1823260-2026-00606
    Event Type
    Malfunction
    Date Received
    February 20, 2026
    Date of Event
    January 24, 2026
    Report Date
    April 15, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K191899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ALBUMIN REAGENT EXPIRATION DATE WAS 31-MAR-2027. THE CALCIUM REAGENT EXPIRATION DATE WAS 31-OCT-2026. THE GLUCOSE REAGENT EXPIRATION DATE WAS 31-MAY-2026. THE TOTAL PROTEIN REAGENT EXPIRATION DATE WAS 31-AUG-2026. THE PROVIDED CALIBRATION SHOWED NO PROBLEMS. THE PROVIDED QC WAS ACCEPTABLE PRIOR TO THE EVENT. THE PROVIDED ALARM TRACE SHOWED 1.4 ABS ALARMS (PHOTOMETER CHECK), ABNORMAL ASPIRATION (SAMPLE PIPETTER S1) ALARMS, AND SAMPLE SHORT S1 ALARMS. THESE ARE INDICATORS OF POSSIBLE POOR SAMPLE QUALITY. THE FIELD SERVICE ENGINEER (FSE) FOUND THAT THE REACTION CELLS WERE OVERFLOWING, THE WATER BATH WATER WAS DIRTY, THE REACTION CELLS NEEDED TO BE REPLACED, THE VACUUM LINK WAS FULL OF DEBRIS, AND THE RINSE MECHANISM VALVES WERE LEAKING. HE CLEANED THE WATER BATH, REPLACED THE REACTION CELLS, CLEANED THE VACUUM SYSTEM, REPLACED THE LEAKING VALVES IN THE RINSE MECHANISM, AND REPLACED THE SOLENOID VALVE. HE THEN PERFORMED CHECKS AND PRECISION STUDIES, AND THEY WERE WITHIN SPECIFICATIONS. THE CUSTOMER PERFORMED QC WITH SUCCESSFUL RESULTS. THE FSE VERIFIED THAT THE INSTRUMENT WAS PERFORMING WITHIN SPECIFICATIONS. THE SERVICE ACTIONS PERFORMED BY THE FSE RESOLVED THE ISSUE. NO FURTHER ISSUES WERE REPORTED AFTER THE SERVICE VISIT. THE ROOT CAUSE WAS FOUND TO BE A HARDWARE ISSUE (ISSUE WITH THE SOLENOID VALVE).

    Additional Manufacturer Narrative · 0

    THE ALBUMIN REAGENT LOT NUMBER WAS 907494. THE CALCIUM REAGENT LOT NUMBER WAS 894309. THE GLUCOSE REAGENT LOT NUMBER WAS 860069. THE TOTAL PROTEIN REAGENT LOT NUMBER WAS 883217. THE ALBUMIN, CALCIUM, GLUCOSE, AND TOTAL PROTEIN REAGENTS' EXPIRATION DATES WERE NOT PROVIDED. THE CUSTOMER HAD CHANGED THE LAMP THE DAY BEFORE THE EVENT. THE FIELD SERVICE ENGINEER (FSE) FOUND THAT THE REACTION CELLS WERE FULL OF FLUID AND THE BATH WATER WAS CLOUDY. HE ALSO FOUND DEBRIS IN THE VACUUM LINE, THE VALVES IN THE RINSE MECHANISM WERE LEAKING, AND THE SOLENOID VALVE HAD AN ISSUE. THE FSE REPLACED THE REACTION CELLS, THE BATH WATER, AND THE VALVES. HE THEN PERFORMED BLEACHING OF THE VACUUM SYSTEM AND REPLACED THE SOLENOID VALVE AND THE COMPRESSOR PARTS. HE PERFORMED AIR PURGE, REAGENT FLOW PATH, AND CELL RINSE ADJUSTMENTS. THE FSE THEN PERFORMED A HARDWARE CHECK, PRECISION STUDIES, AND QC, AND THEY WERE WITHIN SPECIFICATIONS. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH ALBUMIN BCP ASSAY, CALCIUM GEN.2 ASSAY, GLUCOSE HK GEN.3 ASSAY, AND TOTAL PROTEIN GEN.2 ASSAY ON A COBAS C 503 ANALYTICAL UNIT. ALBUMIN: INITIAL RESULT: 1.830 G/DL. REPEAT RESULT: 3.150 G/DL. CALCIUM: INITIAL RESULT: 4.44 MG/DL. REPEAT RESULT: 8.94 MG/DL. GLUCOSE: INITIAL RESULT: 39.5 MG/DL. REPEAT RESULT: 108 MG/DL. TOTAL PROTEIN: INITIAL RESULT: 2.47 G/DL. REPEAT RESULT: 6.61 G/DL. THE CUSTOMER NOTICED THAT THE INITIAL RESULTS WERE LOW AND REPEATED THE SAMPLE ON A DIFFERENT COBAS C 503 ANALYTICAL UNIT. THE REPEAT RESULTS WERE DEEMED TO BE CORRECT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195927 COBAS C 503 ANALYTICAL UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown