BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION EXL(R) CLINICAL CHEMISTRY SYSTEM

    MDR report key: 4404694 · Received January 9, 2015

    Report

    Report Number
    1226181-2015-00023
    Event Type
    Malfunction
    Date Received
    January 9, 2015
    Date of Event
    December 12, 2014
    Report Date
    December 13, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - BROOKFIELD
    Product Code
    JJE
    PMA / PMN Number
    K944093
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE FALSELY DEPRESSED NA, K, AND CL RESULTS IS AN OBSTRUCTION OF THE PINCH VALVE OF THE INTEGRATED MULTISENSOR MODULE. A SIEMENS HEALTHCARE DIAGNOSTICS CUSTOMER SERVICE ENGINEER WAS DISPATCHED TO THE ACCOUNT AND PERFORMED THE NECESSARY REPAIRS. THE CUSTOMER CONFIRMING PROPER OPERATION BY RUNNING QC. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    FALSELY DEPRESSED RESULTS WERE OBTAINED ON SODIUM (NA), POTASSIUM (K) AND CHLORIDE (CL) ON QC AND PATIENT SAMPLES. SOME PATIENT RESULTS WERE REPORTED TO PHYSICIANS. THE SAMPLES WERE REPEATED ON AN ALTERNATE DIMENSION EXL SYSTEM AND HIGHER RESULTS WERE OBTAINED AND REPORTED. IT IS UNKNOWN IF PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED ON THE BASIS OF THE FALSELY DEPRESSED NA, K, AND CL RESULTS. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY ELEVATED NA, K, AND CL RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22495 DIMENSION EXL(R) CLINICAL CHEMISTRY SYSTEM DIMENSION EXL(R) CLINICAL CHEMISTRY SYSTEM JJE SIEMENS HEALTHCARE DIAGNOSTICS INC - BROOKFIELD DIMENSION EXL

    Patients

    Seq Age Sex Outcome Treatment
    1