BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION XPAND W HM

    MDR report key: 3180623 · Received June 20, 2013

    Report

    Report Number
    1226181-2013-00271
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    May 26, 2013
    Report Date
    May 27, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JGS
    PMA / PMN Number
    K112999
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS TECHNICAL SOLUTIONS CENTER (TSC). THE TSC DISCOVERED THAT THE CUSTOMER IS CENTRIFUGING PATIENT SAMPLES OUTSIDE OF THE TUBE VENDOR SPECIFICATIONS AND IS ONLY SPINNING 5 MINUTES VERSUS VENDOR SPECIFICATION OF 10 MINUTES. AFTER EVALUATION THE TSC SPECIALIST DID NOT FIND AN INSTRUMENT MALFUNCTION. QUALITY CONTROLS WERE RUN BY THE CUSTOMER, ALL OF WHICH WERE WITHIN RANGE. THE CUSTOMER ALSO RAN ALL PATIENT SAMPLES FROM THE SAME DAY AND ALL RESULTED AS EXPECTED. THE CAUSE OF THE DISCORDANT, FALSELY ELEVATED SODIUM AND POTASSIUM RESULTS IS UNKNOWN. THE SAMPLE TUBES BEING USED OUTSIDE OF THE TUBE VENDOR SPECIFICATIONS IS FAILURE TO FOLLOW INSTRUCTIONS. THIS INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT, FALSELY ELEVATED SODIUM AND POTASSIUM RESULTS WERE OBTAINED FOR TWO SAMPLES OF ONE PATIENT ON A DIMENSION XPAND W HM INSTRUMENT. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). CUSTOMER DID NOT HAVE SAMPLE TO RERUN SO AT A LARGER HOSPITAL ANOTHER SAMPLE (SAMPLE 2) WAS COLLECTED FROM THE PATIENT AND RUN AND RESULTED LOWER. SAMPLE 2 RESULTS WERE REPORTED TO THE PHYSICIAN(S) THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED SODIUM AND POTASSIUM RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280462 DIMENSION XPAND W HM CLINICAL CHEMISTRY ANALYZER JGS SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION XPAND W HM

    Patients

    Seq Age Sex Outcome Treatment
    1