BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION EXL WITH LM

    MDR report key: 2980737 · Received February 27, 2013

    Report

    Report Number
    1226181-2013-00095
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 31, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K073604
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS TECHNICAL SOLUTIONS CENTER (TSC) TO REPORT THE DISCORDANT SODIUM RESULT. THE TSC SPECIALIST RECOMMENDED THAT A SIEMENS FIELD SERVICE ENGINEER (FSE) BE DISPATCHED TO THE CUSTOMER SITE. THE CUSTOMER DISCUSSED THE DISCORDANT RESULT WITH THE FSE, BUT DECLINED A SERVICE VISIT BECAUSE THE RERUN RESULTS HAD BEEN OBTAINED ON THE SAME INSTRUMENT. THE CAUSE OF THE DISCORDANT, FALSELY LOW SODIUM RESULT IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT, FALSELY LOW SODIUM RESULT WAS OBTAINED ON ONE PATIENT SAMPLE ON A DIMENSION EXL WITH LM INSTRUMENT. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS RERUN IN DUPLICATE. IT IS UNKNOWN IF THE CORRECTED RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE WERE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW SODIUM RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85388 DIMENSION EXL WITH LM IMMUNOASSAY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS DIMENSION EXL WITH LM

    Patients

    Seq Age Sex Outcome Treatment
    1