BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C 303 ANALYTICAL UNIT

    MDR report key: 22393540 · Received July 3, 2025

    Report

    Report Number
    1823260-2025-02034
    Event Type
    Malfunction
    Date Received
    July 3, 2025
    Date of Event
    June 10, 2025
    Report Date
    July 3, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K220134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REAGENT LOT NUMBER IS 831343. THE EXPIRATION DATE WAS NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE REPLACED AND ADJUSTED THE SAMPLE PROBE AND PERFORMED CHECKS AND TESTS WITH ACCEPTABLE RESULTS. AFTER SERVICE, NO ISSUES WERE REPORTED BY THE CUSTOMER. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE TINA-QUANT C-REACTIVE PROTEIN IV RESULTS FOR 2 PATIENT SAMPLES ON A COBAS C 303 ANALYTICAL UNIT. PATIENT (B)(6): THE INITIAL RESULT WAS 7.88 MG/L WITH A DATA FLAG, AND THE REPEATED RESULT WAS 151 MG/L. PATIENT (B)(6): ON (B)(6) 2025, THE INITIAL RESULT WAS 0.54 MG/L WITH A DATA FLAG, AND THE REPEATED RESULT WAS 6.72 MG/L. THE REPEATED RESULTS WERE BELIEVED TO BE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1188066 COBAS C 303 ANALYTICAL UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female