BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP INTACT PARATHYROID HORMONE (IPTH) ASSAY

    MDR report key: 6070703 · Received November 1, 2016

    Report

    Report Number
    1219913-2016-00198
    Event Type
    Malfunction
    Date Received
    November 1, 2016
    Date of Event
    October 17, 2016
    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
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2016-00198 ON NOVEMBER 1, 2016. ON 11/02/2016 CORRECTION: THE 510K NUMBER REPORTED IN THE INITIAL MDR WAS INCORRECT. THE CORRECT 510K NUMBER IS K133601.

    Additional Manufacturer Narrative · 1

    THE CAUSE OF THE DISCORDANT NEAT ADVIA CENTAUR XP IPTH RESULT COMPARED TO THE 1:5 DILUTED RESULT IS UNKNOWN. THERE IS NO AVAILABLE SAMPLE AVAILABLE FOR ADDITIONAL TESTING. THE RESULTS ARE CONSISTENT WITH AN INTERFERENT IN THE SAMPLE. WITHOUT THE SAMPLE, NO ADDITIONAL TESTING CAN BE PERFORMED. QC WAS IN RANGE WHEN THE EVENT OCCURRED. NO FURTHER INVESTIGATION IS REQUIRED. THE INTENDED USE SECTION OF THE INSTRUCTIONS FOR USE (IFU) 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, ADVIA CENTAUR XP, AND ADVIA CENTAUR XPT SYSTEMS. THIS ASSAY IS INTENDED TO BE USED TO AID IN THE DIFFERENTIAL DIAGNOSIS OF HYPERPARATHYROIDISM AND HYPOPARATHYROIDISM." THE LIMITATIONS SECTION OF THE IFU STATES THE FOLLOWING: "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."

    Description of Event or Problem · 1

    CUSTOMER OBSERVED AN ELEVATED NEAT ADVIA CENTAUR XP INTACT PARATHYROID HORMONE (IPTH) RESULT THAT WAS DISCORDANT TO A 1:5 DILUTION OF THE SAMPLE. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP IPTH RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720595 ADVIA CENTAUR XP INTACT PARATHYROID HORMONE (IPTH) ASSAY IPTH IMMUNOASSAY CEW SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 53035363

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR