BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR VITAMIN D TOTAL (VITD) ASSAY

    MDR report key: 3288021 · Received August 14, 2013

    Report

    Report Number
    1219913-2013-00178
    Event Type
    Malfunction
    Date Received
    August 14, 2013
    Date of Event
    June 21, 2013
    Report Date
    August 9, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MRG
    PMA / PMN Number
    K110586
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER PERFORMED A MINI PRECISION STUDY. THE CV WAS HIGH (>27%). A MINI PRECISION RUN WAS PERFORMED BY DILUTING MCM LEVEL 5 AND THE CV WAS ALSO HIGH. A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE FOR INSTRUMENT EVALUATION. THE FSE CHECKED THE ANCILLARY AND SAMPLE PROBE ALIGNMENTS AND REPLACED THE ANCILLARY DILUTOR. A MINI PRECISION RUN WAS PERFORMED AFTER THE ANCILLARY DILUTOR WAS REPLACED AND THE CV WAS ACCEPTABLE (7%). THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATION. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. INSTRUMENT INFORMATION: BRAND NAME: ADVIA CENTAUR, COMMON DEVICE NAME: IMMUNOASSAY ANALYZER, MODEL #: ADVIA CENTAUR, CATALOG #: 078-A002-XX, 510(K): K041133, SERIAL NUMBER: (B)(4).

    Description of Event or Problem · 1

    DISCORDANT ADVIA CENTAUR VITAMIN D TOTAL RESULTS WERE OBTAINED ON QUALITY CONTROL (QC) MATERIAL DURING VALUE ASSIGNMENT STUDIES. THE CUSTOMER REPORTED HIGH CV VALUES FOR DILUTIONS. THE CALIBRATIONS WERE ACCEPTABLE ON BOTH TEST DATES. THE CUSTOMER REPORTED THAT THE QUALITY CONTROL (QC) WAS WITHIN RANGE FOR THE TESTING ON BOTH DATES. ACTUAL QC VALUES WERE NOT PROVIDED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE VITAMIN D TOTAL DISCORDANT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393029 ADVIA CENTAUR VITAMIN D TOTAL (VITD) ASSAY VITD MMUNOASSAY MRG SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 134022

    Patients

    Seq Age Sex Outcome Treatment
    1