BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA(R) CLINICAL CHEMISTRY SYSTEM

    MDR report key: 3486059 · Received November 25, 2013

    Report

    Report Number
    2517506-2013-00410
    Event Type
    Malfunction
    Date Received
    November 25, 2013
    Date of Event
    November 7, 2013
    Report Date
    November 8, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    JFY
    PMA / PMN Number
    K090330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE IMPRECISE ENZYMATIC CREATININE RESULTS IS USER ERROR. THE ACCOUNT SET THE DIGITS OF PRECISION SETTINGS TO ONE (1) WHICH PROVIDED RESULTS IN SINGLE DIGIT OF PRECISION VALUES RATHER THAN THE PROPER THREE DIGITS OF PRECISION. THE SINGLE DIGIT OF PRECISION VALUE SETTING CAUSED RESULT TO BE ROUNDED WITH RESULTING IMPRECISION. THE SIEMENS HEALTHCARE DIAGNOSTICS INC. CUSTOMER CARE CENTER REPRESENTATIVE INSTRUCTED THE ACCOUNT TO CORRECT THE DISGITS OF PRECISION SETTING. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    A GROUP OF IMPRECISE ENZYMATIC CREATININE RESULTS WERE OBTAINED ON PATIENT PLASMA, URINE AND QC SAMPLES. RESULTS WERE REPORTED TO PHYSICIANS. RESULTS WERE REPORTED IN WHOLE NUMBER, SINGLE DIGIT OF PRECISION VALUES ONLY. IT IS UNKNOWN IF PATIENT TREATMENT WAS ALTERED OR PRESCRIBED ON THE BASIS OF THE IMPRECISE CREATININE RESULTS. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE IMPRECISE CREATININE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614434 DIMENSION VISTA(R) CLINICAL CHEMISTRY SYSTEM ENZYMATIC CREATININE FLEX(R) REAGENT CARTRIDGE JFY SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW 13141AB

    Patients

    Seq Age Sex Outcome Treatment
    1