BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMMULITE

    MDR report key: 1744404 · Received June 29, 2010

    Report

    Report Number
    2247117-2010-00020
    Event Type
    Other
    Date Received
    June 29, 2010
    Date of Event
    May 30, 2010
    Report Date
    May 31, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJQ
    PMA / PMN Number
    K970227
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS HEALTHCARE FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE FOR INSTRUMENT EVAL. ANALYSIS OF THE INSTRUMENT AND THE INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCORDANT ESTRADIOL RESULT IS UNK. THE INSTRUMENT IS PERFORMING WITHIN SPECS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT LOW ESTRADIOL RESULT WAS OBTAINED ON ONE (1) PT SAMPLE. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE LABORATORY QUESTIONED THE RESULT DUE TO THE PT'S HISTORY, AND THE SAMPLE WAS REPEATED. THE SAMPLE WAS DILUTED AND A SECOND REPEAT WAS DONE (THE DILUTED SAMPLE WAS ASSIGNED A DIFFERENT SAMPLE IDENTIFIER). PT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ESTRADIOL RESULTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1