BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA (R) CLINICAL CHEMISTRY SYSTEM

    MDR report key: 2397918 · Received January 4, 2012

    Report

    Report Number
    2517506-2011-00182
    Event Type
    Malfunction
    Date Received
    January 4, 2012
    Date of Event
    December 15, 2011
    Report Date
    December 15, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    KHP
    PMA / PMN Number
    K061792
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE FALSELY ELEVATED LACTIC ACID 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 LACTIC ACID RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. A REPEAT OF THE SAME SAMPLE WAS RUN ON AN ALTERNATE VISTA INSTRUMENT AND A LOWER RESULT WAS OBTAINED. PATIENT TREATMENT WAS NOT REPORTED TO HAVE BEEN ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY ELEVATED LACTIC ACID RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIMENSION VISTA (R) CLINICAL CHEMISTRY SYSTEM LACTIC ACID I FLEX® REAGENT CARTRIDGE KHP SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW 11206AE

    Patients

    Seq Age Sex Outcome Treatment
    1