BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA® CLINICAL CHEMISTRY SYSTEM

    MDR report key: 2463257 · Received February 21, 2012

    Report

    Report Number
    2517506-2012-00034
    Event Type
    Malfunction
    Date Received
    February 21, 2012
    Date of Event
    January 28, 2012
    Report Date
    January 31, 2012
    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
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE FALSELY ELEVATED SODIUM RESULT IS UNKNOWN. 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 NOT REPORTED TO THE PHYSICIAN. THE RESULT WAS DISCORDANT WITH REPEATS ON AN ALTERNATE ANALYZER SYSTEM. THE PATIENT WAS TREATED ON THE BASIS OF THE RESULTS ON THE ALTERNATE SYSTEM. THE REPEAT TESTING ON THE DIMENSION VISTA SYSTEM WERE DISCORDANT WITH THE TREATMENT WHEREAS THE RESULTS ON THE ALTERNATE ANALYZER SYSTEM WERE CONSISTENT WITH EXPECTATION. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED ON THE BASIS OF THE DIMENSION VISTA(R) RESULT. 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 V-LYTE® INTEGRATED MULTISENSOR JGS SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW 1HD890

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO