BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP VITAMIN D TOTAL (VITD) ASSAY

    MDR report key: 3770651 · Received April 24, 2014

    Report

    Report Number
    1219913-2014-00098
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    March 18, 2014
    Report Date
    April 1, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MRG
    PMA / PMN Number
    K110586
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT VITAMIN D TOTAL RESULTS IS UNKNOWN. THE PATIENT SAMPLE HAS BEEN REQUESTED FOR FURTHER TESTING. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATION. 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."

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2014-00098 ON APRIL 24, 2014.06/10/2014 ADDITIONAL INFORMATION:THE CUSTOMER SENT ONE PATIENT SAMPLE TO SIEMENS HEALTHCARE DIAGNOSTICS FOR FURTHER TESTING AND INVESTIGATION. THE PATIENT SAMPLE WAS TREATED WITH THE HETEROPHILIC BLOCKING TUBE (HBT). THE RESULT WAS 67.73 NG/ML. DILUTIONS WERE PERFORMED ON THE PATIENT SAMPLE. VITAMIN D SAMPLE DILUTION RESULTS:DILUTION DOSE OBSERVED DOSE THEORETICAL % RECOVERYLOWN 15.7 15.7 1001:2 - 216.5 N/A1:4 108.3 116.1 107%1:8 49.4 65.9 133%1:16 32.0 40.8 127%1:32 22.8 28.3 124%BASED ON THE DATA ABOVE, THE CAUSE FOR THE HIGH RESULT APPEARS TO BE A SAMPLE SPECIFIC ISSUE, SUCH AS SOME UNIDENTIFIED INTERFERENCE. 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." THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A FALSE HIGH ADVIA CENTAUR XP VITAMIN D RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE RESULTS WERE DISCORDANT WITH THREE ALTERNATE METHODS. A SECOND SAMPLE WAS TESTED AND THE RESULT WAS HIGH. 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
    249891 ADVIA CENTAUR XP VITAMIN D TOTAL (VITD) ASSAY VITD MMUNOASSAY MRG SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 052

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR