BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C 303 ANALYTICAL UNIT

    MDR report key: 21252645 · Received January 28, 2025

    Report

    Report Number
    1823260-2025-00254
    Event Type
    Malfunction
    Date Received
    January 28, 2025
    Date of Event
    January 13, 2025
    Report Date
    January 28, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K220134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REAGENT LOT NUMBER WAS 801767. THE EXPIRATION DATE WAS NOT PROVIDED. THE FIELD SERVICE ENGINEER REPLACED THE REACTION CELLS AND CONFIRMED THE CORRECT CELL RINSE ADJUSTMENTS. REPLACEMENT OF THE CELLS IS PART OF CUSTOMER MAINTENANCE AND APPEARED TO NOT HAVE BEEN DONE ACCORDING TO THE SCHEDULE. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE HEMOGLOBIN A1C RESULTS FROM THE COBAS PURE C 303 ANALYTICAL UNIT. THE INITIAL RESULT WAS 9.13 %. THE REPEAT RESULTS AFTER REMIXING THE PRIMARY SAMPLE TUBE WERE 5.39% AND 5.46%. THE RESULT OF 5.39% WAS BELIEVED TO BE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2397103 COBAS C 303 ANALYTICAL UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown