BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR VITAMIN D TOTAL (VIT D)

    MDR report key: 2850757 · Received November 29, 2012

    Report

    Report Number
    1219913-2012-00400
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    November 2, 2012
    Report Date
    November 2, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MRG
    PMA / PMN Number
    K110586
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER NOTED THAT THE QUALITY CONTROL RESULTS WERE RUN IN THE MORNING AND WERE OUT OF THE RANGE LIMITS. NO PATIENT SAMPLES WERE REPORTED AND THE CUSTOMER REQUESTED A FIELD SERVICE VISIT. A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE FOR SYSTEM INSPECTION. THE FSE VERIFIED ALIGNMENT OF THE ANCILLARY PROBE AND ADJUSTED REAGENT PROBE 1 AND 2 ALIGNMENT TO THE CUVETTE AND REAGENT READY PACKS. THE FSE VERIFIED THAT QUALITY CONTROL RESULTS WERE WITHIN ACCEPTABLE LIMITS. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER INVESTIGATION IS REQUIRED.

    Description of Event or Problem · 1

    A FALSELY ELEVATED ADVIA CENTAUR VITAMIN D RESULT WAS OBTAINED ON A PATIENT SAMPLE AND CONSIDERED DISCORDANT WHEN COMPARED TO THE REPEAT TEST RESULTS. THE CUSTOMER PERFORMED REPEAT TESTING ON AN ALTERNATE TEST SAMPLE TUBE OF THE SAMPLE PATIENT AND THE RESULTS WERE LOWER. THE LOW VITAMIN D RESULT WAS REPORTED. THERE WAS NO KNOWN REPORT OF PATIENT TREATMENT BEING ALTERED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED VITAMIN D ASSAY RESULT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1