BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP INTACT PTH (IPTH) ASSAY

    MDR report key: 5406002 · Received February 2, 2016

    Report

    Report Number
    1219913-2016-00023
    Event Type
    Malfunction
    Date Received
    February 2, 2016
    Date of Event
    January 8, 2016
    Report Date
    January 8, 2016
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    CEW
    PMA / PMN Number
    K133601
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2016-00023 ON 02/02/2016 FOR AN ELEVATED ADVIA CENTAUR XP IPTH RESULT. ON 02/29/2016 CORRECTED DATA: SIEMENS CONFIRMED THAT THE DATE OF EVENT WAS (B)(6) 2016, AND NOT (B)(6) 2016 AS ORIGINALLY REPORTED.

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE ELEVATED ADVIA CENTAUR XP IPTH RESULT IS UNKNOWN, HOWEVER THE CUSTOMER OBSERVED A LOWER IPTH DILUTION RESULT, AND REPORTED TO THE PHYSICIAN THAT THERE WAS SAMPLE INTERFERENCE. THE CUSTOMER'S QUALITY CONTROL RESULTS WERE WITHIN ACCEPTABLE RANGES, AND THERE WERE NO OBSERVED ISSUES WITH OTHER PATIENT RESULTS. THE CUSTOMER HAS INFORMED SIEMENS THAT THERE IS NO PATIENT SAMPLE AVAILABLE FOR FURTHER INVESTIGATION, AND HAS DECLINED A SERVICE VISIT. THE INSTRUCTION FOR USE (IFU) STATES IN THE LIMITATION SECTION: "RESULTS SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH THE PATIENT'S MEDICAL HISTORY, CLINICAL PRESENTATION, AND OTHER FINDINGS. INTERPRETATION OF INTACT PTH VALUES SHOULD ALWAYS TAKE INTO ACCOUNT SERUM CALCIUM RESULTS AND THE INTERRELATIONSHIP BETWEEN THESE TWO ELEMENTS IN VARIOUS DISORDERS INVOLVING PTH AND CALCIUM. IT IS RECOMMENDED THAT THE INTACT PTH RESULTS SHOULD ALWAYS BE INTERPRETED WITH CAUTION AND WITH CONSIDERATION OF THE OVERALL CLINICAL MANIFESTATIONS EVEN WHEN USED IN CONJUNCTION WITH CALCIUM VALUES." "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 VALUES MAY BE OBSERVED. ADDITIONAL INFORMATION MAY BE REQUIRED FOR DIAGNOSIS." THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    AN ELEVATED ADVIA CENTAUR XP IPTH RESULT WAS OBTAINED BY THE CUSTOMER AND THE REPORTED RESULT WAS QUESTIONED BY THE PHYSICIAN. THE PHYSICIAN REQUESTED THE IPTH TEST BE REPEATED AND THE RESULT WAS ELEVATED. THE PATIENT RETURNED FOR NEW BLOOD WORK AND THE IPTH RESULT WAS ELEVATED. THE PHYSICIAN REQUESTED THAT THIS SAMPLE BE REPEATED, THE IPTH RESULT WAS ELEVATED. THE PHYSICIAN REQUESTED THE CUSTOMER DILUTE THE PATIENT SAMPLE AND THE IPTH TEST RESULT WAS LOWER. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP IPTH RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61797 ADVIA CENTAUR XP INTACT PTH (IPTH) ASSAY IPTH IMMUNOASSAY, PRODUCT CODE: CEW SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 056352

    Patients

    Seq Age Sex Outcome Treatment
    1