BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP INTACT PARATHYROID HORMONE (IPTH) ASSAY

    MDR report key: 6101520 · Received November 15, 2016

    Report

    Report Number
    1219913-2016-00206
    Event Type
    Malfunction
    Date Received
    November 15, 2016
    Date of Event
    October 19, 2016
    Report Date
    January 18, 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 1219913-2016-00206 WAS FILED ON NOVEMBER 15, 2016 REPORTING AN ELEVATED ADVIA CENTAUR XP INTACT PARATHYROID HORMONE (IPTH) RESULT THAT DID NOT FIT THE CLINICAL PICTURE OR THE RESULT FROM AN ALTERNATE METHOD. DECEMBER 29, 2016 - ADDITIONAL INFORMATION. NO CLINICAL HISTORY AVAILABLE FOR PATIENT AVAILABLE OTHER THAN PAST VITAMIN D DEFICIENCY AND ELEVATED ALKALINE PHOSPHATASE. CALCIUM WAS NOT PERFORMED ON THE SAMPLE. HETEROPHILIC BLOCKING TUBE TESTING WAS NOT PERFORMED ON THE SAMPLE. SIEMENS PERFORMED A 1:5 DILUTION ON THE SAMPLE AND OBSERVED A VALUE OF 0 PMOL/L. THE DILUTED VALUE APPEARS TO BE CONSISTENT WITH AN INTERFERENCE. THE MOST LIKELY REASON FOR THE FALSELY ELEVATED RESULTS IS A SAMPLE SPECIFIC ISSUE WHICH MOST LIKELY MAY BE DUE TO SOME UNIDENTIFIED INTERFERENCE.

    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. SIXTEEN 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 AN ELEVATED ADVIA CENTAUR XP INTACT PARATHYROID HORMONE (IPTH) RESULT THAT DID NOT FIT THE CLINICAL PICTURE OR THE RESULT FROM AN ALTERNATE METHOD. THE RESULT FROM THE ALTERNATE METHOD WAS REPORTED. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED ADVIA CENTAUR XP IPTH RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752781 ADVIA CENTAUR XP INTACT PARATHYROID HORMONE (IPTH) ASSAY IPTH IMMUNOASSAY CEW SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 49783362

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR