BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR INTACT PTH (IPTH) ASSAY

    MDR report key: 5458400 · Received February 24, 2016

    Report

    Report Number
    1219913-2016-00049
    Event Type
    Malfunction
    Date Received
    February 24, 2016
    Date of Event
    December 22, 2015
    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
    WI, 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. THE FSE PERFORMED A TOTAL SERVICE CALL AND NO ISSUES WERE IDENTIFIED. THE TECHNICAL APPLICATION SPECIALIST (TAS) RAN THE MASTER CURVE MATERIAL (MCM) AND THE RESULTS WERE ACCEPTABLE. THE PATIENT SAMPLES ARE NOT AVAILABLE FOR FURTHER TESTING AND INVESTIGATION. THE CAUSE FOR THE DISCORDANT IPTH RESULTS IS UNKNOWN. 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."

    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.

    Description of Event or Problem · 1

    DISCORDANT ADVIA CENTAUR IPTH RESULTS WERE OBTAINED FOR SAMPLES FROM THE SAME PATIENT. THE PHYSICIAN QUESTIONED THE FALSELY ELEVATED RESULT. THE PHYSICIAN WAS EXPECTING A MUCH LOWER RESULT. PATIENT TREATMENT WAS NOT 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
    113095 ADVIA CENTAUR INTACT PTH (IPTH) ASSAY IPTH IMMUNOASSAY CEW SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 352

    Patients

    Seq Age Sex Outcome Treatment
    1