BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION EXL

    MDR report key: 3100871 · Received May 8, 2013

    Report

    Report Number
    1226181-2013-00210
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Date of Event
    April 5, 2013
    Report Date
    April 9, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    NGS
    PMA / PMN Number
    K944093
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE AND ANALYZED THE INSTRUMENT AND INSTRUMENT DATA. THE FSE DETERMINED THAT THE CAUSE OF THE DISCORDANT SODIUM AND POTASSIUM RESULTS WERE DUE TO USER ERROR; IMPROPER SAMPLE TUBE SPINNING. THE TUBE VENDOR RECOMMENDS PULLING 100 - 1300 G FORCE FOR 10 MINUTES IN ORDER TO GET A CLEAN SAMPLE. SIEMENS INSTRUCTED THE CUSTOMER TO FOLLOW THE TUBE MANUFACTURER'S RECOMMENDATION FOR PROPER CENTRIFUGATION TIMES AND SPEEDS. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS AND FURTHER EVALUATION OF THE DEVICE IS NOT REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT SODIUM (NA) AND POTASSIUM (K) RESULTS WERE OBTAINED ON A DIMENSION EXL INSTRUMENT FOR THREE PATIENTS. THE INITIAL RESULTS WERE NOT REPORTED TO THE PHYSICIANS. THE SAMPLES WERE RETESTED AND THE REPEATED RESULTS WERE REPORTED TO THE PHYSICIANS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT SODIUM AND POTASSIUM RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201408 DIMENSION EXL CLINICAL CHEMISTRY SYSTEM NGS SIEMENS HEALTHCARE DIAGNOSTICS DIMENSION EXL

    Patients

    Seq Age Sex Outcome Treatment
    1