BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA 500

    MDR report key: 7484694 · Received May 3, 2018

    Report

    Report Number
    2517506-2018-00315
    Event Type
    Malfunction
    Date Received
    May 3, 2018
    Date of Event
    April 8, 2018
    Report Date
    June 5, 2018
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    UDI-DI
    00630414949581
    PMA / PMN Number
    K051087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC). THE CCC SPECIALIST DETERMINED THAT QUALITY CONTROLS (QC) IS WITHIN ACCEPTABLE RANGES. THE CUSTOMER PERFORMED A PRECISION RUN WITH THE ORIGINAL SAMPLE. THE PRECISION WAS PERFORMED ON THREE CUPS AND ALL THE RESULTS WERE 130 -131. THE CCC STATED THE CUSTOMER WAS OPERATIONAL, THE ISSUE RESOLVED, AND THE CUSTOMER DID NOT REQUEST ADDITIONAL SERVICE. THE CAUSE OF THE DISCORDANT RESULT IS UNKNOWN. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 2517506-2018-00315 ON 03-MAY-2018. ADDITIONAL INFORMATION (07-MAY-2018): A SIEMENS HEADQUARTER SUPPORT CENTER (HSC) SPECIALIST REVIEWED SYSTEM DATA AND SERVICE PERFORMED. THE CALIBRATION SLOPES WERE IN RANGE, THE PERISTALTIC PUMP RATE WAS ACCEPTABLE AND WITHIN SPECIFICATIONS. QUALITY CONTROLS (QC) WERE IN RANGE AT THE TIME OF DISCREPANT RESULT, AND REPEATS OF THE SAMPLE WERE IN EXPECTED RANGE. DATA LOGS INDICATED AN OBSTRUCTION OF FLUID FLOW IN THE INTEGRATED MULTISENSOR TECHNOLOGY (IMT) SYSTEM, LEADING TO THE DISCREPANT PATIENT RESULT. FLUID VERIFICATION FOR THE INITIAL RUN OF SAMPLE ID (B)(6) WAS LOW WITH A CORRESPONDING LOW FLUID DELTA, WHICH IS AN INDICATOR OF A POOR QUALITY SAMPLE OR OTHER DEBRIS THAT PASSED THROUGH THE SENSOR AT THE TIME OF MEASUREMENT. HSC DETERMINED THAT THE POTENTIAL CAUSE OF THE DISCREPANT RESULT WAS DUE TO POOR SAMPLE QUALITY. THE PRESENCE OF GEL, FIBRIN, AND/OR CELLULAR MATERIAL IN SAMPLE(S) POTENTIALLY CONTRIBUTED TO THE SAMPLE QUALITY. THE SYSTEM IS PERFORMING WITHIN SPECIFICATION. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT FALSELY ELEVATED SODIUM RESULT WAS OBTAINED ON A DIMENSION VISTA 500 INSTRUMENT. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE CUSTOMER USED THE SAME SAMPLE TO PERFORM REPEAT TESTING ON THE SAME INSTRUMENT AND ALTERNATE INSTRUMENT. THE REPEATED RESULT WAS HIGHER AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCE DUE TO THE DISCORDANT, FALSELY ELEVATED SODIUM RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325787 DIMENSION VISTA 500 CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA 500 00630414949581

    Patients

    Seq Age Sex Outcome Treatment
    1