BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA 1500

    MDR report key: 3513574 · Received December 10, 2013

    Report

    Report Number
    1226181-2013-00537
    Event Type
    Malfunction
    Date Received
    December 10, 2013
    Date of Event
    November 15, 2013
    Report Date
    November 15, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    JJE
    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 TECHNICAL SERVICE CONSULTANT WAS CONTACTED BY THE CUSTOMER. THE TSC EVALUATED THE INSTRUMENT DATA AND DETERMINED THAT THE CAUSE OF THE DISCORDANT MG, K AND CA RESULTS WAS DUE TO USER ERROR. THE TSC DETERMINED THAT THE INSTRUMENT OPERATOR INSTALLED THE INCORRECT FILTER ON THE WATER PURIFICATION MODULE (WPM). THE QGARD FILTER WAS INCORRECTLY REPLACED WITH A PROGARD FILTER ON THE WPM DURING ROUTINE INSTRUMENT MAINTENANCE. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. FURTHER EVALUATION OF THE DEVICE IS NOT REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT MAGNESIUM (MG), POTASSIUM (K) AND CALCIUM (CA) RESULTS WERE OBTAINED ON A DIMENSION VISTA 1500 INSTRUMENT ON SEVEN PATIENTS. THE DISCORDANT RESULTS WERE RELEASED TO THE PHYSICIAN(S) AND QUESTIONED. THE SAMPLES WERE RERUN ON AN ALTERNATE INSTRUMENT AND THOSE RESULTS WERE REPORTED TO THE PHYSICIAN(S) AS THE CORRECTED RESULTS. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT MG, K AND CA RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646600 DIMENSION VISTA 1500 CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION VISTA 1500

    Patients

    Seq Age Sex Outcome Treatment
    1