BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP INTACT PARATHYROID (IPTH) ASSAY

    MDR report key: 4391246 · Received January 7, 2015

    Report

    Report Number
    1219913-2014-00319
    Event Type
    Malfunction
    Date Received
    January 7, 2015
    Date of Event
    November 18, 2014
    Report Date
    November 14, 2016
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    CEW
    PMA / PMN Number
    K121981
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2014-00319 ON JANUARY 7, 2015. ON 11/02/2016 CORRECTION: THE 510K NUMBER REPORTED IN THE INITIAL MDR WAS INCORRECT. THE CORRECT 510K NUMBER IS K133601.

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT IPTH RESULTS APPEARS TO BE INTERFERENCE OF HETEROPHILIC ANTIBODIES. THE CUSTOMER STATED THE PATIENT HAS NO IGA WHICH MIGHT INDICATE A LARGER NUMBER OF OTHER ANTIBODIES. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. THE IFU STATES UNDER THE LIMITATIONS 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."

    Description of Event or Problem · 1

    FALSELY HIGH ADVIA CENTAUR XP IPTH RESULTS WERE OBTAINED FOR TWO SAMPLES FROM THE SAME PATIENT. THE PATIENT SAMPLE WAS DILUTED AND THE RESULTS WERE LOWER. THE PATIENT SAMPLE WAS SENT TO ANOTHER LABORATORY USING AN ALTERNATE METHOD AND THE RESULT WAS LOWER. THE HIGH RESULTS WERE QUESTIONED BY THE PHYSICIAN. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. 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
    10671 ADVIA CENTAUR XP INTACT PARATHYROID (IPTH) ASSAY IPTH IMMUNOASSAY CEW SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 44359344

    Patients

    Seq Age Sex Outcome Treatment
    1