BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA® CLINICAL CHEMISTRY SYSTEM

    MDR report key: 2701813 · Received August 16, 2012

    Report

    Report Number
    9610806-2012-00009
    Event Type
    Malfunction
    Date Received
    August 16, 2012
    Date of Event
    July 25, 2012
    Report Date
    July 31, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
    Product Code
    CFQ
    PMA / PMN Number
    K990552
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE FALSELY DEPRESSED IGA RESULT IS UNKNOWN. THE DIMENSION VISTA(R) IGA FLEX(R) REAGENT CARTRIDGE IFU IN THE LIMITATIONS OF "PROCEDURE SECTION STATES: ""THE IGA METHOD HAS BEEN DESIGNED TO MINIMIZE ANTIGEN EXCESS IN THE INITIAL SAMPLE DILUTION. HOWEVER, IT CANNOT BE COMPLETELY ELIMINATED AND IN RARE CASES VERY HIGH IMMUNOGLOBULIN CONCENTRATIONS MAY PRODUCE FALSELY-LOW RESULTS. MONOCLONAL IMMUNOGLOBULINS MAY SHOW REACTIVITY DIFFERENT FROM THE POLYCLONAL CALIBRATOR, WHICH IN ISOLATED CASES MAY LEAD TO ARTIFICIALLY DECREASED OR NON-LINEAR RESULTS."" THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT LOW IMMUNOGLOBULIN A (IGA) RESULT WAS REPORTED ON A PATIENT SAMPLE. THE RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THE PATIENT WAS TESTED BY AN ALTERNATE METHODOLOGY (ELECTROPHORESIS) AND ELEVATED RESULTS WERE OBTAINED. THE ORIGINAL SAMPLE WAS RETESTED AND AN ELEVATED RESULT WAS OBTAINED AND REPORTED. IT IS UNKNOWN IF PATIENT TREATMENT WAS ALTERED OR PRESCRIBED. THERE IS NO REPORT OF ADVERSE OUTCOME TO THE PATIENT AS A RESULT OF INITIAL FALSELY DEPRESSED IGA RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIMENSION VISTA® CLINICAL CHEMISTRY SYSTEM IMMUNOGLOBULIN A FLEX® REAGENT CARTRIDGE CFQ SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH 11251MA

    Patients

    Seq Age Sex Outcome Treatment
    1