BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA 500

    MDR report key: 3864507 · Received June 10, 2014

    Report

    Report Number
    1226181-2014-00322
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 16, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    JJE
    PMA / PMN Number
    K051087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SIEMENS HEADQUARTERS SUPPORT CENTER (HSC) WAS CONTACTED BY THE CUSTOMER. THE HSC EVALUATED THE INSTRUMENT DATA, WHICH SHOWED SIGNS OF MATERIAL IN THE INTEGRATED MULTISENSOR TECHNOLOGY FLUIDICS MODULE. THE HSC ALSO DETERMINED THAT THE CUSTOMER WAS USING STATSPIN EXPRESS 4 AND HORIZON PLASMAFUGE-12 CENTRIFUGES THAT WERE SET AT 5000 RPM FOR 5 MINUTES. THIS SET UP IS NOT WITHIN THE TUBE MANUFACTURER'S INSTRUCTIONS. THE HSC RECOMMENDED THAT THE CUSTOMER REVIEW THE PROPER PRE-ANALYTICAL SAMPLE HANDLING PROCEDURES PROVIDED IN THE TUBE MANUFACTURERS INSTRUCTIONS FOR USE. THE CAUSE OF THE DISCORDANT SODIUM RESULTS IS UNKNOWN. THE CAUSE OF THE IMPROPER SAMPLE HANDLING IS FAILURE TO FOLLOW INSTRUCTIONS. THE CUSTOMER SUCCESSFULLY PERFORMED A ROUTINE CLEAN AND RAN QC. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. FURTHER EVALUATION OF THE DEVICE IS NOT REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT, FALSELY LOW SODIUM (NA) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES ON A DIMENSION VISTA 500 INSTRUMENT. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THEM. THE SAMPLES WERE REPEATED ON THE SAME INSTRUMENT. THE CORRECTED RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT NA RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340843 DIMENSION VISTA 500 CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION VISTA 500

    Patients

    Seq Age Sex Outcome Treatment
    1