BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA CLINICAL CHEMISTRY SYSTEM

    MDR report key: 4199661 · Received October 24, 2014

    Report

    Report Number
    1226181-2014-00523
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Date of Event
    September 29, 2014
    Report Date
    September 30, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JGS
    PMA / PMN Number
    K051087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS HEADQUARTERS SUPPORT CENTER (HSC) SPECIALIST EVALUATED THE INSTRUMENT DATA, WHICH INDICATED THAT THE INTEGRATED MULTISENSOR TECHNOLOGY (IMT) SYSTEM DILUTION OF THE SAMPLE WAS IMPACTED BY PARTICULATE MATTER PRESENT IN THE SAMPLE. THE SAMPLE HAD ARRIVED PRE-CENTRIFUGED TO THE LAB AND THE SAMPLE HANDLING DETAILS ARE UNKNOWN. THERE WERE NO ADDITIONAL DISCORDANT ELECTROLYTE RESULTS FOR OTHER PATIENT SAMPLES. THE CAUSE OF THE DISCORDANT NA, K, AND CL RESULTS ON ONE PATIENT SAMPLE IS RELATED TO POOR SAMPLE QUALITY. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT, FALSELY LOW RESULTS WERE OBTAINED ON ONE PATIENT SAMPLE TESTED FOR SODIUM (NA), POTASSIUM (K), AND CHLORIDE (CL) ON A DIMENSION VISTA 1500 INSTRUMENT. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO SENT THE PATIENT TO AN EMERGENCY ROOM (ER). THE PATIENT WAS REDRAWN AT THE ER AND THE NEW SAMPLE WAS TESTED AT THE ER CLINIC LAB, RESULTING HIGHER FOR NA. THE K AND CL RESULTS FROM THE SAMPLE OBTAINED IN THE ER ARE UNKNOWN. THE LABORATORY THEN REPEATED THE INITIAL SAMPLE ON AN ALTERNATE DIMENSION VISTA INSTRUMENT AND THE NA, K, AND CL RESULTS WERE ALL HIGHER. 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, K, AND CL RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678739 DIMENSION VISTA CLINICAL CHEMISTRY SYSTEM CLINICAL CHEMISTRY ANALYZER JGS SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA 1500

    Patients

    Seq Age Sex Outcome Treatment
    1