BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C 503 ANALYTICAL UNIT

    MDR report key: 24221998 · Received January 30, 2026

    Report

    Report Number
    1823260-2026-00321
    Event Type
    Malfunction
    Date Received
    January 30, 2026
    Date of Event
    January 10, 2026
    Report Date
    January 30, 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 GLUCOSE REAGENT LOT NUMBER WAS 882312 WITH AN EXPIRATION DATE OF 31-AUG-2026. THE TOTAL PROTEIN REAGENT LOT NUMBER WAS 883217 WITH AN EXPIRATION DATE OF 31-AUG-2026. THE CALIBRATION WAS LAST PERFORMED ON (B)(6) 2025. THE QC WAS OUT OF RANGE. THE ALARM TRACE SHOWED AN ABNORMAL ASPIRATION (SAMPLE PIPETTER) ALARM. THE FIELD SERVICE ENGINEER CHECKED THE ANALYZER AND FOUND THAT THE CAUSE WAS DUE TO DEBRIS ON THE TIP OF THE SAMPLE PROBE. HE CLEANED, ADJUSTED, AND VERIFIED THE SAMPLE PROBE. HE ALSO CLEANED THE SONIC WASH STATION AND CHECKED THE SAMPLE RINSE STATION FOR PROPER WATER LEVEL. THE CUSTOMER PERFORMED QC, AND IT WAS WITHIN SPECIFICATIONS. THE SERVICE ACTIONS PERFORMED BY THE ENGINEER RESOLVED THE ISSUE. NO FURTHER ISSUES WERE REPORTED AFTER THE SERVICE VISIT.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH GLUCOSE HK GEN.3 ASSAY AND TOTAL PROTEIN GEN.2 ASSAY ON A COBAS C 503 ANALYTICAL UNIT. GLUCOSE: INITIAL RESULT: 28 MG/DL. REPEAT RESULT: 167 MG/DL. TOTAL PROTEIN: INITIAL RESULT: 1.4 G/DL. REPEAT RESULT: 8.0 G/DL. THE CUSTOMER QUESTIONED THE INITIAL RESULTS AND REPEATED THE SAMPLE ON A DIFFERENT ANALYZER. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE REPEAT RESULTS WERE DEEMED TO BE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284249 COBAS C 503 ANALYTICAL UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown