BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITAMIN D TOTAL (VITD) ADVIA CENTAUR ASSAY

    MDR report key: 2872534 · Received December 13, 2012

    Report

    Report Number
    1219913-2012-00415
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    November 21, 2012
    Report Date
    November 21, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MRG
    PMA / PMN Number
    K110586
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT VITAMIN D TOTAL RESULTS IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATION. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. THE IFU STATES IN THE RESULTS SECTION: "RESULTS SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH THE PATIENT'S MEDICAL HISTORY, CLINICAL PRESENTATION, AND OTHER FINDINGS." THE IFU STATES IN THE LIMITATIONS SECTION: "HETEROPHILIC ANTIBODIES IN HUMAN SERUM CAN REACT WITH REAGENT IMMUNOGLOBULINS, INTERFERING WITH IN VITRO IMMUNOASSAYS. PATIENTS ROUTINELY EXPOSED TO ANIMALS OR TO ANIMAL SERUM PRODUCTS CAN BE PRONE TO THIS INTERFERENCE AND ANOMALOUS VALUES MAY BE OBSERVED. ADDITIONAL INFORMATION MAY BE REQUIRED FOR DIAGNOSIS."

    Description of Event or Problem · 1

    ELEVATED ADVIA CENTAUR XP VITAMIN D RESULTS WERE OBTAINED ON SAMPLES FROM FOUR DIFFERENT PATIENTS. THE SAMPLES WERE DILUTED AND TESTED. THE RESULTS WERE LOWER. THE PATIENT SAMPLES WERE TESTED AGAIN NEAT AND THE RESULTS WERE LOWER. THE DILUTED RESULTS WERE REPORTED. IT IS UNKNOWN IF PATIENT TREATMENT WAS PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE VITAMIN D DISCORDANT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITAMIN D TOTAL (VITD) ADVIA CENTAUR ASSAY VITD MMUNOASSAY MRG SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 021

    Patients

    Seq Age Sex Outcome Treatment
    1