BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA® CLINICAL CHEMISTRY SYSTEM

    MDR report key: 3003837 · Received March 14, 2013

    Report

    Report Number
    1226181-2013-00111
    Event Type
    Malfunction
    Date Received
    March 14, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 12, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC- BROOKFIELD
    Product Code
    JJE
    PMA / PMN Number
    K051087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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 ESTRADIOL RESULT IS UNKNOWN. THE SIEMENS HEALTHCARE DIAGNOSTICS TECHNICAL SERVICE CENTER (TSC) REPRESENTATIVE DIRECTED THE CUSTOMER TO PROPERLY MONITOR THE DILUENT VIAL VOLUMES USED FOR ESTRADIOL DETERMINATIONS REQUIRING DILUTIONS. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A FALSELY ESTRADIOL (E2) RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAMPLE WAS REPEATED AND A HIGHER RESULT WAS OBTAINED AND REPORTED. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED ON THE BASIS OF THE FALSELY DEPRESSED ESTRADIOL RESULT. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY DEPRESSED ESTRADIOL RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107265 DIMENSION VISTA® CLINICAL CHEMISTRY SYSTEM DIMENSION VISTA® CLINICAL CHEMISTRY SYSTEM JJE SIEMENS HEALTHCARE DIAGNOSTICS INC- BROOKFIELD VISTA 1500

    Patients

    Seq Age Sex Outcome Treatment
    1