BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR IPTH ASSAY

    MDR report key: 1080215 · Received July 17, 2008

    Report

    Report Number
    1219913-2008-00057
    Event Type
    Other
    Date Received
    July 17, 2008
    Date of Event
    June 9, 2008
    Report Date
    June 24, 2008
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.,
    Product Code
    CEW
    PMA / PMN Number
    K020217
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DIFFERENCES IN PATIENT RESULTS BETWEEN THE ADVIA CENTAUR AND THE ALTERNATE IPTH ASSAY METHODS IS UNKNOWN. THE CAUSE FOR THE DISCORDANT RESULTS MAY BE SAMPLE SPECIFIC. A SAMPLE FROM THIS PATIENT HAS BEEN REQUESTED FOR FURTHER INVESTIGATION. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A CUSTOMER COMPLAINED THAT ADVIA CENTAUR INTACT PTH (IPTH) PATIENT RESULTS WERE LOWER THAN OTHER MANUFACTURERS IPTH ASSAYS. BECAUSE THE PHYSICIAN ANTICIPATED AN ELEVATED IPTH BASED ON THE PATIENT'S HISTORY, THEY MONITORED THE IPTH RESULTS BEFORE, DURING, AND AFTER PARATHYROID SURGERY USING THE ADVIA CENTAUR AND ANOTHER MANUFACTURERS IPTH ASSAY. 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 IPTH ASSAY IPTH IMMUNOASSAY CEW SIEMENS HEALTHCARE DIAGNOSTICS INC., NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1