BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION® CLINICAL CHEMISTRY SYSTEM

    MDR report key: 1699886 · Received May 26, 2010

    Report

    Report Number
    2517506-2010-00052
    Event Type
    Malfunction
    Date Received
    May 26, 2010
    Date of Event
    May 1, 2010
    Report Date
    May 1, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC
    Product Code
    JFY
    PMA / PMN Number
    K090330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    LOW CREATININE RESULTS HAVE BEEN ATTRIBUTED TO CARRYOVER FROM PHOSPHORUS REAGENT INTO CREATININE. CUSTOMER HAS BEEN ADVISED TO RUN EACH OF THESE REAGENTS ON SEPARATE SERVERS TO ELIMINATE THE PROBLEM. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    SPORADIC FALSELY DEPRESSED CREATININE RESULTS WERE OBTAINED ON PATIENT SAMPLES. IT IS UNKNOWN IF RESULTS WERE REPORTED TO THE PHYSICIAN. THERE WERE NO REPORTS OF ANY ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY DEPRESSED CREATININE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIMENSION® CLINICAL CHEMISTRY SYSTEM ENZYMATIC CREATININE FLEX® REAGENT CARTRIDGE JFY SIEMENS HEALTHCARE DIAGNOSTICS, INC 10011AF

    Patients

    Seq Age Sex Outcome Treatment
    1