BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA® CLINICAL CHEMISTRY SYSTEM

    MDR report key: 2839781 · Received November 20, 2012

    Report

    Report Number
    2517506-2012-00308
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    October 16, 2012
    Report Date
    October 16, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    CGN
    PMA / PMN Number
    K071224
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE FALSELY ELEVATED FOLATE RESULTS IS USER ERROR. THE ACCOUNT HAD ENTERED THE CALIBRATOR VALUES FOR THE INCORRECT UNIT OF MEASURE (NMOL/L) RATHER THAN THE CORRECT UNIT OF MEASURE (NG/ML). THE SIEMENS HEALTHCARE DIAGNOSTICS INC TECHNICAL SERVICE CENTER REPRESENTATIVE DIRECTED THE CUSTOMER TO ENTER THE CORRECT UNIT OF MEASURE VALUES FOR THE CALIBRATORS AND TO RECALIBRATE. THIS RESOLVED THE ISSUE. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    FALSELY ELEVATED FOLATE (FOL) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES. THE PATIENT RESULTS WERE REPORTED TO THE PHYSICIAN. REPEATS WERE RUN AFTER CORRECTION OF A CALIBRATION ERROR AND LOWER FOLATE RESULTS WERE OBTAINED AND REPORTED. IT IS UNKNOWN IF PATIENT TREATMENT WAS ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY ELEVATED FOLATE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIMENSION VISTA® CLINICAL CHEMISTRY SYSTEM FOLATE FLEX® REAGENT CARTRIDGE CGN SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW 12188AA

    Patients

    Seq Age Sex Outcome Treatment
    1