BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA® CLINICAL CHEMISTRY SYSTEM

    MDR report key: 3063395 · Received April 17, 2013

    Report

    Report Number
    1226181-2013-00178
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 19, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC-BROOKFIELD
    Product Code
    CGA
    PMA / PMN Number
    K051087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 GLUCOSE RESULT IS SAMPLE INTEGRITY CAUSED BY AN ALIQUOT PROBE DRAIN OVERFLOW. THE SIEMENS HEALTHCARE DIAGNOSTICS TECHNICAL SERVICE CENTER REPRESENTATIVE DIRECTED THE CUSTOMER TO PERFORM MAINTENANCE ACTIVITIES TO CLEAN THE ALIQUOT PROBE DRAIN. SUBSEQUENT QC WAS WITHIN RANGE. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATION. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    FALSELY ELEVATED GLUCOSE RESULTS WERE OBTAINED ON A PATIENT SAMPLE. THE PATIENT RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE TEST WAS RE-RUN ON AN ALTERNATE DIMENSION VISTA INSTRUMENT AND A LOWER RESULT WAS OBTAINED AND REPORTED. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY ELEVATED GLUCOSE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165758 DIMENSION VISTA® CLINICAL CHEMISTRY SYSTEM DIMENSION® VISTA® CLINICAL CHEMISTRY SYSTEM CGA SIEMENS HEALTHCARE DIAGNOSTICS INC-BROOKFIELD DIMENSION VISTA 1500

    Patients

    Seq Age Sex Outcome Treatment
    1