BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP INTACT PARATHYROID HORMONE (IPTH) ASSAY

    MDR report key: 6181780 · Received December 16, 2016

    Report

    Report Number
    1219913-2016-00243
    Event Type
    Malfunction
    Date Received
    December 16, 2016
    Date of Event
    November 24, 2016
    Report Date
    April 5, 2017
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    CEW
    PMA / PMN Number
    K133601
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MDR 1219913-2016-00243 WAS FILED ON DECEMBER 16, 2016 REPORTING TWO ADVIA CENTAUR XP INTACT PARATHYROID HORMONE (IPTH) RESULTS EDTA SAMPLE TUBES THAT WERE LOW COMPARED TO RESULTS FROM SERUM TUBES. MARCH 24, 2017 - ADDITIONAL INFORMATION SIEMENS REQUESTED THE FOLLOWING INFORMATION FROM THE CUSTOMER TO INVESTIGATE THE ISSUE: CLARIFICATION OF THE DESCRIPTION OF SHORT TO DESCRIBE THE SAMPLES. WHAT WAS THE INITIAL VALUE BEFORE THE SAMPLE WAS AUTO DILUTED? WHAT WERE THE VALUES REPORTED TO THE PHYSICIAN? DOES THE CUSTOMER TYPICALLY AUTO DILUTE ALL THEIR IPTH SAMPLES? WHAT WAS THE CLINICAL HISTORY OF THE PATIENT? WHAT WAS THE RESULT THE PHYSICIAN WAS EXPECTING ? HOW WERE THE SERUM SAMPLES STORED BEFORE BEING EVALUATED? WERE THEY FROZEN SAMPLES? IF THE SERUM SAMPLES WERE FRESH SAMPLES HOW LONG WERE THEY AT ROOM TEMPERATURE? WERE THE EDTA SAMPLES REPEATED? IF SO WHAT WERE THE REPEATED VALUES? ARE THERE ANY PREVIOUS KNOWN IPTH RESULTS FOR THESE SAMPLES? PLEASE CONFIRM THE TWO PATIENT SAMPLES ARE FROM 2 DIFFERENT PATIENTS. WHAT IS THE CUSTOMER'S REFERENCE RANGE FOR THE IPTH ASSAY? DOES THE CUSTOMER USE DIFFERENT REFERENCE RANGES FOR SERUM AND EDTA OR DO THEY USE THE SAME REFERENCE RANGE? THE INFORMATION REQUESTED WAS NOT PROVIDED. ROOT CAUSE CANNOT BE IDENTIFIED WITH THE INITIAL INFORMATION PROVIDED.

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT IPTH RESULTS IS UNKNOWN. SIEMENS HEALTHCARE DIAGNOSTICS IS INVESTIGATING. THE LIMITATIONS SECTION OF THE INSTRUCTIONS FOR USE STATES: "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. IT SHOULD BE NOTED THAT SOME OVERLAP OF INTACT PTH VALUES DOES EXIST FROM PATIENTS WITH VARIOUS PARATHYROID DISORDERS. MEASUREMENT OF INTACT PTH IS USEFUL IN DIFFERENTIATING BETWEEN HYPERCALCEMIA DUE TO HYPERPARATHYROIDISM AND HYPERCALCEMIA OF MALIGNANCY. HOWEVER, THE ASSAY IS NOT INTENDED AS, AND SHOULD NOT BE RELIED UPON AS, A DIAGNOSTIC INDICATOR OF MALIGNANCY. IT IS ALSO EXTREMELY IMPORTANT TO ENSURE THAT PATIENT SAMPLES HAVE BEEN HANDLED AND STORED CORRECTLY. INCORRECT HANDLING OF SAMPLES WILL RESULT IN A LOSS OF INTACT PTH. THE TYPE OF SPECIMEN USED (SERUM OR EDTA PLASMA) MAY INFLUENCE INTACT PTH MEASUREMENTS. DURING ROUTINE MONITORING OF IPTH LEVELS, TO AVOID BIAS IN THE RESULTS, USE THE SAME SPECIMEN TYPE THROUGHOUT THE MONITORING PERIOD. HETEROPHILIC ANTIBODIES IN HUMAN SERUM CAN REACT WITH REAGENT IMMUNOGLOBULINS, INTERFERING WITH IN VITRO IMMUNOASSAYS.16 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

    CUSTOMER OBSERVED TWO ADVIA CENTAUR XP INTACT PARATHYROID HORMONE (IPTH) RESULTS FROM EDTA SAMPLE TUBES THAT WERE LOW COMPARED TO RESULTS FROM SERUM TUBES. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE LOW ADVIA CENTAUR XP IPTH RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831814 ADVIA CENTAUR XP INTACT PARATHYROID HORMONE (IPTH) ASSAY IPTH IMMUNOASSAY CEW SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 056362

    Patients

    Seq Age Sex Outcome Treatment
    1