BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMMULITE 2000 TOTAL TESTOSTERONE

    MDR report key: 1278486 · Received November 24, 2008

    Report

    Report Number
    2017183-2008-00054
    Event Type
    Other
    Date Received
    November 24, 2008
    Date of Event
    September 19, 2008
    Report Date
    September 23, 2008
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    CDZ
    PMA / PMN Number
    K032881
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE AND COMPLETED PERFORMANCE SERVICE. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THE CAUSE FOR THE DISCORDANT TESTOSTERONE RESULT IS UNK. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    THE INITIAL IMMULITE 200 TESTOSTERONE RESULTS ON A PT SAMPLE WERE ELEVATED. A NEW SAMPLE WAS DRAWN FROM THE SAME PT AND THE TESTOSTERONE RESULTS WERE LOW. THE PHYSICIAN REQUESTED A RETEST; BOTH THE INITIAL SAMPLE AND THE SECOND SAMPLE WERE REPEATED WITH HIGH TESTOSTERONE RESULTS. BECAUSE THE PT HAS POLYCYSTIC OVARY SYNDROME, THE HIGHER RESULTS WERE CORRECT. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TESTOSTERONE RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMULITE 2000 TOTAL TESTOSTERONE TESTOSTERONE IMMUNOASSAY CDZ SIEMENS HEALTHCARE DIAGNOSTICS INC. NA 175

    Patients

    Seq Age Sex Outcome Treatment
    1