BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMMULITE 2000 THIRD GEN TSH

    MDR report key: 1278488 · Received November 24, 2008

    Report

    Report Number
    2017183-2008-00057
    Event Type
    Other
    Date Received
    November 24, 2008
    Date of Event
    September 25, 2008
    Report Date
    September 26, 2008
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    DGC
    PMA / PMN Number
    K970227
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THERE IS NO KNOWN CAUSE FOR THE DISCORDANT THIRD GEN TSH RESULT. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A LOW IMMULITE 2000 THIRD GEN TSH RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE SAMPLE WAS REPEATED AND THE RESULTS WERE HIGHER. THE SAMPLE WAS RETESTED (3X) AND ALL RESULTS WERE HIGHER THAN THE ORIGINAL RESULT. THE HIGHER RESULTS WERE CORRECT. PATIENT TREATMENT WAS NOT ALTERED AND THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT THIRD GEN TSH ASSAY RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMULITE 2000 THIRD GEN TSH TSH IMMUNOASSAY DGC SIEMENS HEALTHCARE DIAGNOSTICS INC. NA 426

    Patients

    Seq Age Sex Outcome Treatment
    1