BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT IPTH

    MDR report key: 1056773 · Received June 3, 2008

    Report

    Report Number
    9610746-2008-00001
    Event Type
    Malfunction
    Date Received
    June 3, 2008
    Date of Event
    February 12, 2008
    Report Date
    May 5, 2008
    Manufacturer
    BIOKIT SA
    Product Code
    CEW
    PMA / PMN Number
    K063232
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    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 ACCOUNT STATED THAT A DISCREPANT RESULT WAS GENERATED USING THE ARCHITECT IPTH REAGENT. A PATIENT WAS UNDERGOING SURGERY FOR PARATHYROID HYPERPLASIA, A BASELINE BLOOD DRAW FOR IPTH WAS COLLECTED INTRAOPERATIVELY WITH THE RESULT OF 732 PG/ML. THE PATHOLOGIST QUESTIONED THE RESULT AND ASKED FOR THE SAMPLE TO BE REPEATED. THE REPEAT RESULT WAS 757.7 PG/ML. A SECOND SAMPLE WAS COLLECTED AND THE RESULT WAS 47 PG/ML, THE 5 MINUTE POST EXCISION RESULT WAS 83 PG/ML, THE 10 MINUTE POST EXCISION RESULT WAS 61 PG/ML. THE QC WAS WITHIN RANGE. UPON REVIEW OF PATIENT HISTORY, THE ACCOUNT STATED THAT IN 2007, THE PATIENT WAS TESTED FOR IPTH ON THE IMMULITE PLATFORM AND THE RESULT WAS 18.5 (UNITS OF MEASURE WERE NOT PROVIDED). THERE IS NO IMPACT TO PATIENT MANAGEMENT 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 01207L000

    Patients

    Seq Age Sex Outcome Treatment
    1 NI ARCHITECT I2000SR ANALYZER| LIST # 3M74-01