BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMMULITE 2500

    MDR report key: 1742972 · Received June 28, 2010

    Report

    Report Number
    2247117-2010-00018
    Event Type
    Other
    Date Received
    June 28, 2010
    Date of Event
    April 28, 2010
    Report Date
    June 1, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    JJQ
    PMA / PMN Number
    K905215
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 EVALUATION. ANALYSIS OF THE INSTRUMENT AND THE INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCORDANT IPTH, FT3 AND FT4 RESULTS CANNOT BE DETERMINED. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT IMMULATE 2500 IPTH, FT3 AND FT4 RESULTS WERE OBTAINED ON PT SAMPLES. THE SAMPLES WERE REPEATED BECAUSE THE INITIAL RESULTS DID NOT AGREE WITH THE PTS CLINICAL HISTORY. PT TREATMENT WAS NOT ALTERED OR PRESCRIBED FOR EITHER PT. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT IPTH, FT3 AND FT4 RESULTS.

    Additional Manufacturer Narrative · 2

    A SIEMENS HEALTHCARE FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE FOR INSTRUMENT EVALUATION. ANALYSIS OF THE INSTRUMENT AND THE INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCORDANT IPTH, FT3 AND FT4 RESULTS CANNOT BE DETERMINED. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 2

    DISCORDANT IMMULATE 2500 IPTH, FT3 AND FT4 RESULTS WERE OBTAINED ON PT SAMPLES. THE SAMPLES WERE REPEATED BECAUSE THE INITIAL RESULTS DID NOT AGREE WITH THE PTS CLINICAL HISTORY. PT TREATMENT WAS NOT ALTERED OR PRESCRIBED FOR EITHER PT. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT IPTH, FT3 AND FT4 RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMULITE 2500 IMMUNO-ASSAY JJQ SIEMENS HEALTHCARE DIAGNOSTICS INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1
    2