BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP INTACT PTH (IPTH) ASSAY

    MDR report key: 2850758 · Received November 29, 2012

    Report

    Report Number
    1219913-2012-00399
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 2, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    CEW
    PMA / PMN Number
    K020217
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT ADVIA CENTAUR IPTH RESULT IS UNKNOWN. QUALITY CONTROLS ARE WITHIN ACCEPTABLE LIMITS AND THERE ARE NO OTHER SYSTEM ISSUES. THE CUSTOMER STATED THAT THE SYSTEM IS OPERATIONAL. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATION. 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: " 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. 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."

    Description of Event or Problem · 1

    A DISCORDANT LOW ADVIA CENTAUR INTACT PTH (IPTH) TEST RESULT WAS OBTAINED BY THE CUSTOMER ON A PATIENT SAMPLE DURING REPEAT TESTING. THERE WAS NO REPORT OF PATIENT TREATMENT BEING PRESCRIBED OR ALTERED AND THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP IPTH 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 315

    Patients

    Seq Age Sex Outcome Treatment
    1