BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP VITAMIN D TOTAL (VITD) ASSAY

    MDR report key: 6151028 · Received December 7, 2016

    Report

    Report Number
    1219913-2016-00237
    Event Type
    Malfunction
    Date Received
    December 7, 2016
    Date of Event
    October 19, 2016
    Report Date
    January 16, 2017
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MRG
    PMA / PMN Number
    K110586
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT VITAMIN D TOTAL RESULT IS UNKNOWN. SIEMENS HEALTHCARE DIAGNOSTICS IS INVESTIGATING. 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."

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2016-00237 ON DECEMBER 7, 2016. SIEMENS FILED THE MDR 1219913-2016-00237 SUPPLEMENTAL REPORT 1 ON DECEMBER 27, 2016. ON 01/10/2017 ADDITIONAL INFORMATION: THE CLINICAL HISTORY OF THE PATIENT WAS NOT PROVIDED. THE D2 AND D3 BREAKDOWN WERE NOT PROVIDED FROM THE LC/MS METHOD. THE ADVIA CENTAUR XP VITAMIN D TOTAL ASSAY IS ALIGNED TO THE GHENT UNIVERSITY REFERENCE METHOD PROCEDURE (RMP). THE VITAMIN D ASSAY IS CDC AND VDSP CERTIFIED. THE CAUSE FOR THE DISCORDANT RESULTS IS POSSIBLY THE DIFFERENCE IN THE ASSAY STANDARDIZATION. THE CAUSE FOR THE DISCORDANT VITAMIN D TOTAL RESULT IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. THE IFU STATES IN THE SUMMARY AND EXPLANATION SECTION: "AS PART OF ITS VITAMIN D INITIATIVE, NIH OFFICE OF DIETARY SUPPLEMENTS (ODS) ESTABLISHED THE VITAMIN D STANDARDIZATION PROGRAM (VDSP) IN NOVEMBER 2010. ODS IS LEADING A COLLABORATIVE EFFORT WITH THE CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) AND THE NATIONAL INSTITUTE FOR STANDARDS AND TECHNOLOGY (NIST) TO STANDARDIZE THE LABORATORY MEASUREMENT OF VITAMIN D STATUS IN NATIONAL HEALTH SURVEYS WORLDWIDE. THE VDSP IS ALSO IN COLLABORATION WITH THE NIST, THE CDC, AND THE UNIVERSITY OF GHENT. THE OBJECTIVES OF THE VDSP ARE TO: -STANDARDIZE THE MEASUREMENT OF SERUM TOTAL 25(OH)VITAMIN D IN NATIONAL HEALTH SURVEYS BY LINKING THEM TO THE NIST REFERENCE MEASUREMENT PROCEDURE. -STUDY SIMILARITIES AND DIFFERENCES IN TOTAL 25(OH)VITAMIN D AMONG NATIONAL HEALTH SURVEYS. -EXPAND STANDARDIZATION SERVICES FROM NATIONAL SURVEYS TO INCLUDE ASSAY MANUFACTURERS AND CLINICAL AND RESEARCH LABORATORIES. -ENABLE THE USE OF STANDARDIZED DATA IN PUBLIC HEALTH ACTIVITIES AND PATIENT CARE. THE UNIVERSITY OF GHENT HAS DEVELOPED AN ID-LC/MS/MS 25(OH)VITAMIN D REFERENCE MEASUREMENT PROCEDURE (RMP) FOR VITAMIN D IN HUMAN SERUM THAT IS TRACEABLE TO NIST STANDARD SRM2972. THIS REFERENCE METHOD WAS USED BY THE NIH AND CDC TO DEVELOP THE STANDARDS USED IN THE VDSP AND THE CDC VITAMIN D CERTIFICATION PROGRAM (VDSCP). THE CDC VDSCP SHOULD HELP LABORATORIES WITH LAB-DEVELOPED TESTS AND ASSAY MANUFACTURERS WITH CALIBRATION. THIS PROGRAM ASSESSES THE ASSAY PERFORMANCE (BIAS AND IMPRECISION) OF THE LAB OR ASSAY MANUFACTURER THROUGHOUT A 1-YEAR PERIOD."

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2016-00237 ON DECEMBER 7, 2016. ON 12/07/2016 ADDITIONAL INFORMATION: THE PATIENT'S DATE OF BIRTH WAS RECEIVED: (B)(6). SAMPLE TUBE TYPE: SERUM. IT IS UNKNOWN HOW LONG THE PATIENT HAS BEEN TAKING THE SUPPLEMENT OSTELIN-D. THE PATIENT HAD FURTHER TESTS DONE ON (B)(6) 2016 FOR PREGNANCY AND VITAMIN D. THE PATIENT IS NOT PREGNANT AND THE VITAMIN D RESULT WAS STILL LOW. THE PATIENT HAS (B)(6). ON (B)(6) 2016 VITAMIN D RESULT: 47.2 NMOL/L. SIEMENS HEALTHCARE DIAGNOSTICS IS INVESTIGATING.

    Description of Event or Problem · 1

    FALSE LOW ADVIA CENTAUR XP VITAMIN D RESULTS WERE OBTAINED ON A PATIENT SAMPLE. THE PHYSICIAN QUESTIONED THE LOW RESULT THAT WAS REPORTED AS THE PATIENT IS ON 4000 U OD OSTELIN-D FOR MEDICATION. THE PATIENT SAMPLE WAS SENT TO ANOTHER SITE FOR TESTING WITH AN ALTERNATE METHOD. THE RESULT WAS HIGHER. A CORRECTED REPORT WAS ISSUED. PATIENT TREATMENT WAS NOT 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
    803761 ADVIA CENTAUR XP VITAMIN D TOTAL (VITD) ASSAY VITD MMUNOASSAY MRG SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 068

    Patients

    Seq Age Sex Outcome Treatment
    1