BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP VITAMIN D TOTAL (VITD) ASSAY

    MDR report key: 2830211 · Received November 13, 2012

    Report

    Report Number
    1219913-2012-00398
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Date of Event
    October 11, 2012
    Report Date
    October 16, 2012
    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

    (B)(4) 2013: THE CUSTOMER USED REAGENT LOT # 010 WHEN COMPARING TO REAGENT LOT # 020. THE BIAS OBSERVED BY THE CUSTOMER BETWEEN THE REAGENT LOTS IS NOT WHAT IS EXPECTED WHEN CORRELATING TO THE NEWLY RECALIBRATED VITAMIN D LOT #020. SIEMENS HEALTHCARE DIAGNOSTICS RECOMMENDED TO REPEAT THE CORRELATION STUDY USING FRESH REAGENTS AND ANCILLARY PACK. SIEMENS HAS PUBLISHED CUSTOMER BULLETIN "RECALIBRATION OF THE VITAMIN D TOTAL ASSAY BEGINNING WITH REAGENT LOT 134020" (10813470 REV. A) DATED 2012-08. NO OTHER DATA OR INFORMATION WAS PROVIDED BY THE CUSTOMER.

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE BIAS VITAMIN D TOTAL RESULTS IS UNKNOWN. SIEMENS HEALTHCARE DIAGNOSTICS IS INVESTIGATING THE ISSUE AT THE CUSTOMER SITE.

    Description of Event or Problem · 1

    HIGH BIAS ADVIA CENTAUR XP VITAMIN D TOTAL RESULTS WERE OBTAINED FOR SIXTEEN SAMPLES FROM DIFFERENT PATIENTS WHEN COMPARING REAGENT LOT # 020 WITH PREVIOUS REAGENT LOTS. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR XP VITAMIN D TOTAL (VITD) ASSAY VITD IMMUNOASSAY MRG SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 020

    Patients

    Seq Age Sex Outcome Treatment
    1