BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA® SYSTEM

    MDR report key: 1715324 · Received June 9, 2010

    Report

    Report Number
    2517506-2010-00057
    Event Type
    Malfunction
    Date Received
    June 9, 2010
    Date of Event
    May 7, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC
    Product Code
    JFY
    PMA / PMN Number
    K090330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE FALSELY ELEVATED CREATININE RESULTS WAS CARRYOVER OF TOTAL PROTEIN (TP) REAGENT INTO CREATININE(ECREA). THE CUSTOMER WAS ADVISED TO MOVE TP AND ECREA TO SEPARATE SERVERS TO ELIMINATE THE PROBLEM.

    Description of Event or Problem · 1

    SEVERAL FALSELY ELEVATED CREATININE RESULTS WERE OBTAINED ON PATIENTS' SAMPLES. IT IS UNKNOWN IF THE RESULTS WERE REPORTED TO THE PHYSICIAN. THE SAMPLES WERE REPEATED AND LOWER RESULTS WERE OBTAINED. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY ELEVATED CREATININE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIMENSION VISTA® SYSTEM ECREA FLEX® REAGENT CARTRIDGE JFY SIEMENS HEALTHCARE DIAGNOSTICS, INC 1011AF

    Patients

    Seq Age Sex Outcome Treatment
    1