BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMMULITE 2500 STAT INTACT PTH

    MDR report key: 1278485 · Received November 24, 2008

    Report

    Report Number
    2017183-2008-00045
    Event Type
    Other
    Date Received
    November 24, 2008
    Date of Event
    August 20, 2008
    Report Date
    August 25, 2008
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    CEW
    PMA / PMN Number
    K013566
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCORDANT STAT INTACT PTH RESULTS ARE UNKNOWN. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    A LOWER THAN EXPECTED IMMULITE 2500 STAT INTACT PTH ASSAY RESULT WAS OBTAINED A PATIENT SAMPLE. THE SAMPLE WAS RETESTED TWICE DURING THE PATIENT'S RECOVERY AND THE RESULTS WERE MUCH HIGHER. THESE RESULTS WERE CONFIRMED WITH A DIFFERENT KIT LOT OF REAGENTS AS WELL. PATIENT TREATMENT WAS ALTERED (SURGERY WAS STOPPED), BUT THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT INTACT PTH ASSAY RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMULITE 2500 STAT INTACT PTH STAT INTACT PTH IMMUNOASSAY CEW SIEMENS HEALTHCARE DIAGNOSTICS INC. NA 113

    Patients

    Seq Age Sex Outcome Treatment
    1