BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION® CLINICAL CHEMISTRY SYSTEM

    MDR report key: 2018752 · Received March 15, 2011

    Report

    Report Number
    2517506-2011-00045
    Event Type
    Malfunction
    Date Received
    March 15, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 3, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    CEM
    PMA / PMN Number
    K970330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE LIKELY CAUSE FOR THE FALSELY ELEVATED POTASSIUM RESULT WAS FIBRIN IN THE IMT SENSOR DUE TO SAMPLE INTEGRITY ISSUES WITH A PRIOR SAMPLE. CUSTOMER REPORTS THAT PRIOR TO THIS ELEVATED PATIENT RESULT, TWO OTHER PATIENTS SAMPLES GAVE LOW RESULTS FOR NA, K, & CL. THIS IS SUGGESTIVE OF FIBRIN CONTAMINATION OF THE QUIKLYTE(R) INTEGRATED MULTISENSOR CHANNEL. THE IFU FOR THE DIMENSION QUICKLYTE INTEGRATED MULTISENSOR CONTAINS EXTENSIVE PRE-ANALYTICAL SAMPLE HANDLING PRECAUTIONS AND STATES: "FAILURE TO FOLLOW THE BLOOD COLLECTION TUBE INSTRUCTIONS MAY RESULT IN INCREASED MAINTENANCE OR TROUBLESHOOTING OF THE IMT SYSTEM." THE SIEMENS HEALTHCARE DIAGNOSTICS INC. TECHNICAL SERVICE CENTER REPRESENTATIVE DIRECTED THE CUSTOMER TO REPLACE THE IMT SENSOR. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A FALSELY ELEVATED POTASSIUM (K) RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THE SAMPLE WAS IMMEDIATELY REPEATED AND A LOWER RESULT WITHIN THE NORMAL RANGE 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 POTASSIUM RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIMENSION® CLINICAL CHEMISTRY SYSTEM QUIKLYTE® INTEGRATED MULTISENSOR CEM SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW 0LD837

    Patients

    Seq Age Sex Outcome Treatment
    1