BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT IPTH

    MDR report key: 1065015 · Received June 24, 2008

    Report

    Report Number
    9610746-2008-00003
    Event Type
    Malfunction
    Date Received
    June 24, 2008
    Report Date
    May 27, 2008
    Manufacturer
    BIOKIT SA
    Product Code
    CEW
    PMA / PMN Number
    K063232
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THEY HAVE OBSERVED HIGHER THAN EXPECTED VALUES WHEN TESTING APPARENTLY HEALTHY ADULTS ON THE ARCHITECT INTACT PTH ASSAY. THE SAME SAMPLES GENERATE LOWER VALUES WHEN RETESTED ON THE BAYER CENTAUR. ONE EXAMPLE WAS PROVIDED WHERE A FEMALE PT GENERATED RESULTS BETWEEN 110-70 PG/ML (NORMAL RANGE <68 PG/ML) AND WHEN TESTED ON THE BAYER CENTAUR, THE RESULT WAS 36 PG/ML. NO IMPACT TO PT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT IPTH CMIA FOR THE QUANTITATION DETERMINATION OF IPTH CEW BIOKIT SA NA 01107H000

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR ARCHITECT I2000 SR ANALYZER LIST# 3M74-02