BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMMULITE 2000 XPI INTACT PTH

    MDR report key: 1642581 · Received March 24, 2010

    Report

    Report Number
    2017183-2010-00012
    Event Type
    Other
    Date Received
    March 24, 2010
    Date of Event
    November 18, 2009
    Report Date
    February 24, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    CEW
    PMA / PMN Number
    K013566
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L DATE OF EVENT: (B)(6) 2010. ANALYSIS OF THE SYSTEM DATA INDICATE THAT THERE ARE NO KNOWN CAUSES WHICH MAY HAVE CONTRIBUTED TO THE INITIAL DISCORDANT LOW IMMULITE 2000 IPTH TEST RESULT. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    A DISCORDANT LOW IMMULITE 2000 XPI IPTH ASSAY RESULT WAS OBTAINED AND REPORTED TO THE PHYSICIAN ON (B)(6) 2009. THE PT WAS SCHEDULED FOR FOLLOW UP BLOOD WORK AND PTHRP ON (B)(6) 2010. THE PTHRP TEST WAS NOT AVAILABLE AND THE FOLLOW UP SAMPLE WAS TESTED FOR IPTH AND THE RESULT WAS HIGH. THE SAMPLE WAS SENT OUT FOR TESTING ON ANOTHER IPTH METHOD AND THE RESULT WAS MILDLY INCREASED. THERE WAS NO KNOWN REPORT OF PT TREATMENT BEING ALTERED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE INITIAL LOW DISCORDANT IPTH ASSAY RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMULITE 2000 XPI INTACT PTH INTACT PTH IMMUNOASSAY CEW SIEMENS HEALTHCARE DIAGNOSTICS INC. NA 193

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR