BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMMULITE 2500 INTACT PTH

    MDR report key: 1669095 · Received April 23, 2010

    Report

    Report Number
    2017183-2010-00020
    Event Type
    Other
    Date Received
    April 23, 2010
    Date of Event
    March 12, 2010
    Report Date
    April 1, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    CEW
    PMA / PMN Number
    K013566
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE FOR SYSTEM EVAL. ANALYSIS OF THE SYSTEM DATA INDICATE THAT THERE ARE NO KNOWN SYSTEM ISSUES WHICH COULD HAVE CONTRIBUTED TO THE DISCORDANT LOW IMMULITE 2500 IPTH TEST RESULTS. THE CUSTOMER'S PROCEDURE IS TO INITIALLY FREEZE PT SAMPLES, THAW AND PERFORM TESTING. THE FSE NOTED A CLOT DETECTION ERROR FOR ONE OF THE DISCORDANT PT SAMPLES. IT IS SUSPECTED THAT SAMPLE HANDLING AND FIBRIN MAY BE A CONTRIBUTING FACTOR. THE INSTRUMENT IS PERFORMING WITHIN SPECS.

    Description of Event or Problem · 1

    DISCORDANT LOW IMMULITE 2500 IPTH ASSAY RESULTS WERE OBTAINED BY THE CUSTOMER ON TWO PT SAMPLES. THE CUSTOMER PERFORMED REPEAT TESTING AND THE RESULTS WERE ELEVATED FOR BOTH PTS. THE DISCORDANT LOW RESULTS WERE NOT REPORTED TO THE PHYSICIAN. THERE WAS NO KNOWN REPORT OF PT TREATMENT BEING ALTERED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE LOW DISCORDANT IPTH ASSAY RESULTS.

    Additional Manufacturer Narrative · 2

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE FOR SYSTEM EVAL. ANALYSIS OF THE SYSTEM DATA INDICATE THAT THERE ARE NO KNOWN SYSTEM ISSUES WHICH COULD HAVE CONTRIBUTED TO THE DISCORDANT LOW IMMULITE 2500 IPTH TEST RESULTS. THE CUSTOMER'S PROCEDURE IS TO INITIALLY FREEZE PT SAMPLES, THAW AND PERFORM TESTING. THE FSE NOTED A CLOT DETECTION ERROR FOR ONE OF THE DISCORDANT PT SAMPLES. IT IS SUSPECT THAT SAMPLE HANDLING AND FIBRIN MAY BE A CONTRIBUTING FACTOR. THE INSTRUMENT IS PERFORMING WITHIN SPECS.

    Description of Event or Problem · 2

    DISCORDANT LOW IMMULITE 2500 IPTH ASSAY RESULTS WERE OBTAINED BY THE CUSTOMER ON TWO PT SAMPLES. THE CUSTOMER PERFORMED REPEAT TESTING AND THE RESULTS WERE ELEVATED FOR BOTH PTS. THE DISCORDANT LOW RESULTS WERE NOT REPORTED TO THE PHYSICIAN. THERE WAS NO KNOWN REPORT OF PT TREATMENT BEING ALTERED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE LOW DISCORDANT IPTH ASSAY RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMULITE 2500 INTACT PTH INTACT PTH IMMUNOASSAY CEW SIEMENS HEALTHCARE DIAGNOSTICS INC. NA 252

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR
    2 79 YR