BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2500

    MDR report key: 2303438 · Received October 21, 2011

    Report

    Report Number
    2247117-2011-00063
    Event Type
    Malfunction
    Date Received
    October 21, 2011
    Date of Event
    October 7, 2011
    Report Date
    October 7, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K033234
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS HEALTHCARE DIAGNOSTICS TSE (TECHNICAL SERVICE ENGINEER) ANALYZED THE SYSTEM DATA. AFTER ANALYSIS OF THE SYSTEM DATA, THE TSE CONCLUDED THAT THE CAUSE OF THE DISCORDANT PROGESTERONE (PGN) RESULT IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE SYSTEM IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT HIGH PROGESTERONE (PGN) RESULT WAS OBTAINED WITH ONE (1) PATIENT SAMPLE ON AN IMMULITE 2500 ANALYZER. THE DISCORDANT RESULT WAS RELEASED TO THE PHYSICIAN. THE PHYSICIAN QUESTIONED THE HIGH RESULT BECAUSE IT DIDN'T FIT THE PATIENT'S HISTORY OR THE CLINICAL PICTURE. THE PHYSICIAN SENT THE PATIENT TO A DIFFERENT LABORATORY FACILITY FOR REPEAT TESTING. THE RESULTS OF THE REPEAT TESTING WERE REPORTED. THERE WAS NO KNOWN REPORT OF PATIENT CARE BEING ALTERED OR PRESCRIBED DUE TO THE DISCORDANT PROGESTERONE RESULT. THERE WAS NO KNOWN REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT PROGESTERONE RESULT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1