BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR INTACT PTH (IPTH) ASSAY

    MDR report key: 2001779 · Received February 22, 2011

    Report

    Report Number
    1219913-2011-00018
    Event Type
    Other
    Date Received
    February 22, 2011
    Date of Event
    December 1, 2010
    Report Date
    January 26, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    CEW
    PMA / PMN Number
    K020217
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT IPTH RESULTS IS DUE TO POSSIBLE BIOTIN INTERFERENCE. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. THE IFU STATES IN THE LIMITATIONS SECTION: "HETEROPHILIC ANTIBODIES IN HUMAN SERUM CAN REACT WITH REAGENT IMMUNOGLOBULINS, INTERFERING WITH IN VITRO IMMUNOASSAYS. PATIENTS ROUTINELY EXPOSED TO ANIMALS OR TO ANIMAL SERUM PRODUCTS CAN BE PRONE TO THIS INTERFERENCE AND ANOMALOUS VALVES MAY BE OBSERVED. SAMPLES FROM PATIENTS ROUTINELY RECEIVING HIGH DOSE. BIOTIN THERAPY MAY SHOW FALSELY DEPRESSED RESULTS. ADD'L INFO MAY BE REQUIRED FOR DIAGNOSIS."

    Description of Event or Problem · 1

    DISCORDANT ADVIA CENTAUR IPTH RESULTS WERE OBTAINED FOR A PT SAMPLE. THE ADVIA CENTAUR RESULTS WERE LOWER THAN EXPECTED. THE PT WAS DIAGNOSED WITH PARATHYROID ADENOMA. THE PT SAMPLE WAS SENT OUT TO BE TESTED ON ALTERNATE INSTRUMENTS. THE RESULTS FOR IPTH WERE HIGHER. THE PT SAMPLE WAS ALSO TREATED ON THE MASS SPECTROMETRY AND THE RESULTS WERE HIGHER. PT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT IPTH RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR INTACT PTH (IPTH) ASSAY IPTH IMMUNOASSAY CEW SIEMENS HEALTHCARE DIAGNOSTICS, INC. NA 158

    Patients

    Seq Age Sex Outcome Treatment
    1