BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C 503 ANALYTICAL UNIT

    MDR report key: 23728354 · Received December 5, 2025

    Report

    Report Number
    1823260-2025-04954
    Event Type
    Malfunction
    Date Received
    December 5, 2025
    Date of Event
    November 4, 2025
    Report Date
    January 13, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K191899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE ENGINEER FOUND AN ISSUE WITH A SOLENOID VALVE, WHICH LED TO INCOMPLETE ASPIRATION DURING THE CELL RINSE PROCESS. THE VALVE WAS REPLACED, AND CELL RINSE VOLUME ADJUSTMENTS AND MECHANICAL CHECKS WERE PERFORMED. THE SYSTEM PERFORMANCE WAS VERIFIED THROUGH A CELL BLANK MEASUREMENT AND QC THAT WERE ACCEPTABLE. THE INVESTIGAITON DETERMINED THAT THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Additional Manufacturer Narrative · 0

    THE CHOLESTEROL REAGENT LOT NUMBER WAS 900693 WITH AN EXPIRATION DATE OF 31-MAY-2026. THE HDL-CHOLESTEROL REAGENT LOT NUMBER WAS 858795 WITH AN EXPIRATION DATE OF 31-JAN-2027. THE TOTAL PROTEIN REAGENT LOT NUMBER WAS 883217 WITH AN EXPIRATION DATE OF 31-AUG-2026. THE QC WAS ACCEPTABLE. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH CHOLESTEROL GEN.2 ASSAY, HDL-CHOLESTEROL GEN.4 ASSAY, AND TOTAL PROTEIN GEN.2 ASSAY ON A COBAS C 503 ANALYTICAL UNIT. CHOLESTEROL: INITIAL RESULT: 46 MG/L. REPEAT RESULT: 241 MG/L. HDL-CHOLESTEROL: INITIAL RESULT: 24 MG/L. REPEAT RESULT: 46 MG/L. TOTAL PROTEIN: INITIAL RESULT: 30 G/DL. REPEAT RESULT: 6.3 G/DL. THE PROVIDER'S OFFICE QUESTIONED THE INITIAL RESULTS, PROMPTING THE REPEAT OF THE SAMPLE. THE REPEAT RESULTS WERE DEEMED TO BE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494631 COBAS C 503 ANALYTICAL UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female