BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMMULITE 2500 STAT INTACT PTH

    MDR report key: 1240870 · Received November 6, 2008

    Report

    Report Number
    2017183-2008-00050
    Event Type
    Other
    Date Received
    November 6, 2008
    Date of Event
    September 12, 2008
    Report Date
    September 22, 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
    VT, US
    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 UNK. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A LOW POSITIVE IMMULITE 2500 STAT INTACT PTH PT SAMPLE WAS REPORTED TO THE PHYSICIAN WHO ORDERED THE SAMPLE TO BE REPEATED. UPON REPEAT (2X), THE INTACT PTH RESULTS WERE MORE POSITIVE. PT TREATMENT WAS NOT ALTERED AND THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT STAT 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