BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA 1500

    MDR report key: 3961922 · Received July 28, 2014

    Report

    Report Number
    1226181-2014-00404
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 3, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    JGS
    PMA / PMN Number
    K051087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS TECHNICAL SOLUTIONS CENTER (TSC). THE CUSTOMER STATED THAT THE SAMPLE RESULTED AS EXPECTED UPON REPEAT TESTING ON THE SAME INSTRUMENT. THE CAUSE OF THE DISCORDANT, FALSELY ELEVATED NA AND CL RESULTS IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT, FALSELY ELEVATED SODIUM (NA) AND CHLORIDE (CL) RESULTS WERE OBTAINED ON ONE PATIENT SAMPLE ON A DIMENSION VISTA 1500 INSTRUMENT. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED THREE TIMES ON THE SAME INSTRUMENT, RESULTING LOWER. IT IS UNKNOWN IF THE CORRECTED RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED NA AND CL RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437650 DIMENSION VISTA 1500 CLINICAL CHEMISTRY ANALYZER JGS SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION VISTA 1500

    Patients

    Seq Age Sex Outcome Treatment
    1