BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION® CLINICAL CHEMISTRY SYSTEM

    MDR report key: 2831561 · Received November 14, 2012

    Report

    Report Number
    1226181-2012-00104
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 15, 2012
    Report Date
    October 15, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC- BROOKFIELD
    Product Code
    JGS
    PMA / PMN Number
    K944093
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 SODIUM RESULT WAS A MISALIGNMENT OF THE INTEGRATED MULTISENSOR (IMT) PROBE. THE SIEMENS HEALTHCARE DIAGNOSTICS TECHNICAL SERVICE CENTER REPRESENTATIVE DIRECTED THE CUSTOMER TO TROUBLESHOOTING ACTIVITIES. THE CUSTOMER DISCOVERED THAT THE ALIGNMENT OF THE SAMPLE PROBE TO THE IMT PORT WAS OFF. THE CUSTOMER REPLACED THE SAMPLE PROBE WHICH RESOLVED THE PROBLEM. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A FALSELY ELEVATED SODIUM RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE PATIENT RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE RESULT WAS QUESTIONED WITHIN THE LABORATORY AND THE SAMPLE RE-RUN. THE SAMPLE WAS RE-RUN ON AN ALTERNATE INSTRUMENT AND A LOWER RESULT WAS OBTAINED. A CORRECTED RESULT WAS REPORTED.PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY ELEVATED SODIUM RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIMENSION® CLINICAL CHEMISTRY SYSTEM CLINICAL CHEMISTRY SYSTEM JGS SIEMENS HEALTHCARE DIAGNOSTICS INC- BROOKFIELD EXL

    Patients

    Seq Age Sex Outcome Treatment
    1