BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP INTACT PTH (IPTH) ASSAY

    MDR report key: 2700721 · Received August 15, 2012

    Report

    Report Number
    1219913-2012-00302
    Event Type
    Malfunction
    Date Received
    August 15, 2012
    Date of Event
    July 19, 2012
    Report Date
    July 19, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    CEW
    PMA / PMN Number
    K020217
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE ) WAS SENT TO THE CUSTOMER SITE FOR SYSTEM INSPECTION AND FOUND NO SYSTEM ISSUES THAT MAY HAVE CONTRIBUTED TO THE DISCORDANT RESULT. THE FSE UPDATED THE WASH SEPARATION MANIFOLD. THE CUSTOMER HAD OBSERVED FIBRIN CLOTS IN THE SAMPLE AND THE CAUSE FOR THE FALSELY ELEVATED ADVIA CENTAUR XP IPTH RESULT MAY BE ATTRIBUTED TO SPECIMEN COLLECTION AND HANDLING. THE INSTRUCTION FOR USE (IFU) UNDER THE INTENDED USE SECTION STATES THE FOLLOWING: "FOR IN VITRO DIAGNOSTIC USE IN THE QUANTITATIVE DETERMINATION OF INTACT PARATHYROID HORMONE (IPTH) IN EDTA PLASMA OR SERUM USING THE ADVIA CENTAUR AND ADVIA CENTAUR XP SYSTEMS. THIS ASSAY IS INTENDED TO BE USED TO AID IN THE DIFFERENTIAL DIAGNOSIS OF HYPERPARATHYROIDISM, HYPOPARATHYROIDISM, OR HYPERCALCEMIA OF MALIGNANCY." THE INSTRUCTION FOR USE (IFU) UNDER THE LIMITATION SECTION 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." THE INSTRUCTION FOR USE (IFU) UNDER THE SPECIMEN COLLECTION AND HANDLING SECTION STATES THE FOLLOWING: "BEFORE PLACING SAMPLES ON THE SYSTEM, ENSURE THAT SAMPLES HAVE THE FOLLOWING CHARACTERISTICS: SAMPLES ARE FREE OF FIBRIN OR OTHER PARTICULATE MATTER. SAMPLES ARE FREE OF BUBBLES." THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    A FALSELY ELEVATED ADVIA CENTAUR XP IPTH TEST RESULT WAS OBTAINED ON AN INTRA-OPERATIVE PATIENT SAMPLE AND CONSIDERED DISCORDANT WHEN COMPARED TO A PREVIOUSLY LOWER IPTH TEST RESULT. IT WAS OBSERVED THAT THE SAMPLE HAD FIBRIN CLOTS AND THE OPERATING ROOM WAS NOTIFIED. THE CUSTOMER PERFORMED REPEAT IPTH TESTING FROM ANOTHER SAMPLE AND THE RESULT WAS LOWER. ALL OTHER SUBSEQUENT IPTH SAMPLES RUN ON THAT PATIENT HAD LOWER RESULTS. THERE WAS NO KNOWN REPORT OF PATIENT TREATMENT BEING ALTERED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT IPTH TEST RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR XP INTACT PTH (IPTH) ASSAY IPTH IMMUNOASSAY CEW SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 316

    Patients

    Seq Age Sex Outcome Treatment
    1