BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMMULITE 1000, PROGESTERONE

    MDR report key: 1066026 · Received June 24, 2008

    Report

    Report Number
    2017183-2008-00022
    Event Type
    Other
    Date Received
    June 24, 2008
    Date of Event
    March 12, 2008
    Report Date
    March 12, 2008
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JLX
    PMA / PMN Number
    K944211
    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. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCORDANT PROGESTERONE RESULT IS UNK. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    ELEVATED IMMULITE 1000 PROGESTERONE RESULTS WERE REPORTED TO THE PHYSICIAN ON TWO PTS SAMPLES. THE PHYSICIAN QUESTIONED THE RESULTS BECAUSE THE PROGESTERONE VALUES WERE ELEVATED RELATIVE TO THE PT'S ESTRADIOL LEVELS. BOTH PT SAMPLES WERE RETESTED WITH ANOTHER PROGESTERONE ASSAY AND THE RESULTS WERE LOWER. PT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT PROGESTERONE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMULITE 1000, PROGESTERONE IMMUNOASSAY SYSTEM JLX SIEMENS HEALTHCARE DIAGNOSTICS NA 321

    Patients

    Seq Age Sex Outcome Treatment
    1