BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMMULITE 2000

    MDR report key: 1397216 · Received May 29, 2009

    Report

    Report Number
    2247117-2009-00018
    Event Type
    Other
    Date Received
    May 29, 2009
    Date of Event
    April 29, 2009
    Report Date
    May 1, 2009
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    CHP
    PMA / PMN Number
    K970227
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS HEALTHCARE FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSES OF THE DISCORDANT ESTRADIOL (E2) RESULTS ARE UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT ESTRADIOL (E2) RESULTS WERE OBTAINED ON TWO PATIENT SAMPLES, GENERATED ON IMMULITE 2000. THE SAMPLES WERE REPEATED AND THE RESULTS WERE REPORTED. PATIENTS' TREATMENTS WERE NOT ALTERED OR PRESCRIBED. THERE WERE NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE DISCORDANT ESTRADIOL(E2) RESULTS.

    Additional Manufacturer Narrative · 2

    A SIEMENS HEALTHCARE FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSES OF THE DISCORDANT ESTRADIOL (E2) RESULTS ARE UNKNOWN. THE INSTRUMENTS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 2

    DISCORDANT ESTRADIOL (E2) RESULTS WERE OBTAINED ON TWO PATIENT SAMPLES, GENERATED ON IMMULITE 2000. THE SAMPLES WERE REPEATED AND THE RESULTS WERE REPORTED. PATIENTS' TREATMENTS WERE NOT ALTERED OR PRESCRIBED. THERE WERE NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE DISCORDANT ESTRADIOL(E2) RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMULITE 2000 IMMUNO-ASSAY ANALYZER CHP SIEMENS HEALTHCARE DIAGNOSTICS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1
    2