BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA® CLINICAL CHEMISTRY SYSTEM

    MDR report key: 2588268 · Received May 25, 2012

    Report

    Report Number
    1226181-2012-00024
    Event Type
    Malfunction
    Date Received
    May 25, 2012
    Date of Event
    January 31, 2012
    Report Date
    February 1, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    JGS
    PMA / PMN Number
    K051087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS FILED THE ORIGINAL MDR 2517506-2012-00032 ON 2012-(B)(6) AS CAUSED BY SAMPLE INTEGRITY NEW INFORMATION WAS PROVIDED BY THE SIEMENS HEALTHCARE DIAGNOSTICS INC. FIELD SERVICE ENGINEER (FSE) ON 2012-(B)(6): ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE FALSELY ELEVATED SODIUM RESULT IS MALFUNCTION OF THE IMT PUMP. THE SIEMENS HEALTHCARE DIAGNOSTICS INC. FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE ACCOUNT AND REPLACED THE IMT PUMP. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A FALSELY ELEVATED SODIUM (NA) RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED ON AN ALTERNATE DIMENSION VISTA INSTRUMENT AND A LOWER RESULT WAS OBTAINED. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY ELEVATED SODIUM RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIMENSION VISTA® CLINICAL CHEMISTRY SYSTEM CLINICAL CHEMISTRY SYSTEM JGS SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW VISTA 500

    Patients

    Seq Age Sex Outcome Treatment
    1