BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA® CLINICAL CHEMISTRY SYSTEM

    MDR report key: 2616959 · Received June 14, 2012

    Report

    Report Number
    2517506-2012-00109
    Event Type
    Malfunction
    Date Received
    June 14, 2012
    Date of Event
    May 14, 2012
    Report Date
    May 21, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    JFY
    PMA / PMN Number
    K090330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE IMPRECISE CREATININE RESULT IS USER ERROR. THE ACCOUNT SET THE DIGITS OF PRECISION SETTING TO ONE WHICH PROVIDED RESULTS IN INTEGER VALUES ONLY RATHER THAN THE PROPER THREE DIGITS OF PRECISION. THE LACK OF SIGNIFICANT DIGITS CAUSE RESULTS TO BE ROUNDED WITH RESULTING IMPRECISION AT LOW ANALYTE VALUES. THE SIEMENS HEALTHCARE DIAGNOSTICS INC. TECHNICAL SERVICE CENTER REPRESENTATIVE INSTRUCTED THE ACCOUNT TO CORRECT THE DIGITS OF PRECISION SETTING. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A GROUP OF IMPRECISE CREATININE RESULTS WAS OBTAINED ON PATIENT AND QC SAMPLES. RESULTS WERE WAS REPORTED TO THE PHYSICIAN. RESULTS WERE REPORTED IN WHOLE NUMBER VALUES ONLY. IT IS UNKNOWN IF PATIENT TREATMENT WAS ALTERED OR PRESCRIBED AS A RESULT OF THE IMPRECISE CREATININE RESULTS. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE IMPRECISE CREATININE RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIMENSION VISTA® CLINICAL CHEMISTRY SYSTEM ENZYMATIC CREATININE FLEX® REAGENT CARTRIDGE JFY SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW 12033AE

    Patients

    Seq Age Sex Outcome Treatment
    1