BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA® INTELLIGENT LAB SYSTEM

    MDR report key: 1930777 · Received December 16, 2010

    Report

    Report Number
    2517506-2010-00140
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    November 11, 2010
    Report Date
    November 17, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    JGS
    PMA / PMN Number
    K051087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE FALSELY ELEVATED SODIUM RESULT WAS INTERFERENCE FROM THIOPENTAL. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A FALSELY ELEVATED SODIUM RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED AND A NORMAL RESULT WAS OBTAINED. THIOPENTAL ADMINISTRATION WAS DISCONTINUED. 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® INTELLIGENT LAB SYSTEM V- LYTE® INTEGRATED MULTISENSOR JGS SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW OFD892

    Patients

    Seq Age Sex Outcome Treatment
    1