BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR INTACT PTH (IPTH) ASSAY

    MDR report key: 4345659 · Received December 19, 2014

    Report

    Report Number
    1219913-2014-00295
    Event Type
    Malfunction
    Date Received
    December 19, 2014
    Date of Event
    September 4, 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
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON 11/02/2016 CORRECTION:THE 510K NUMBER REPORTED IN THE INITAL MDR WAS INCORRECT. THE CORRECT 510K NUMBER IS K133601.

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT IPTH RESULTS WITH THE ALTERNATE METHOD IS UNKNOWN. INCONSISTENCIES IN PATIENTS RESULTS MAY BE DUE TO THE DIFFERENCES IN THE STANDARDISATION AND THE REFERENCE MATERIAL USED TO STANDARDIZE THE ASSAY METHODS. VARIABILITY MAY ALSO BE DRIVEN TO THE SPECIFICITY OF THE ANTIBODY USED AND THE DETECTION OF THE VARIOUS N TERMINAL PTH FRAGMENTS. AS THIS PATIENT IS A RENAL DIALYSIS PATIENT, THE PROBABILITY OF INTACT PARATHYROID FRAGMENTS BEING PRODUCED AND POTENTIALLY CAUSING VARIABILITY IN THE PATIENT RESULTS CAN NOT BE RULED OUT. 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. 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."

    Description of Event or Problem · 1

    FALSELY HIGH ADVIA CENTAUR IPTH RESULTS WERE OBTAINED FOR SAMPLES FROM THE SAME PATIENT OVER A PERIOD OF THREE MONTHS. THE PATIENT SAMPLES WERE TESTED ON AN ALTERNATE METHOD AND THE RESULTS WERE LOWER. THE HIGH RESULTS WERE QUESTIONED BY THE PHYSICIAN. THE PATIENT'S THYROID WAS REMOVED AND TRANSPLANTED INTO THE UPPER ARM ABOUT A YEAR AGO. THE PATIENT IS ON DIALYSIS FOR RENAL FAILURE. IT IS UNKNOWN IF PATIENT TREATMENT WAS 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
    838773 ADVIA CENTAUR INTACT PTH (IPTH) ASSAY IPTH IMMUNOASSAY CEW SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 340

    Patients

    Seq Age Sex Outcome Treatment
    1