BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP VITAMIN D TOTAL (VIT D)

    MDR report key: 2862556 · Received December 10, 2012

    Report

    Report Number
    1219913-2012-00404
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 7, 2012
    Report Date
    November 9, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MRG
    PMA / PMN Number
    K110586
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS ON SITE FOR SYSTEM INSPECTION. THE FSE PERFORMED A FUNCTIONAL SYSTEM CHECK AND VERIFIED SYSTEM ALIGNMENTS AND CALIBRATIONS. THE CAUSE FOR THE INITIALLY REACTIVE ADVIA CENTAUR XP VITAMIN D RESULTS WHEN COMPARED TO LOWER REPEAT VITAMIN D TEST RESULTS IS UNKNOWN. THE CUSTOMER'S QUALITY CONTROL RESULTS HAD SHIFTED HIGH WHEN COMPARED TO THE QUALITY CONTROL RESULTS FROM THE PREVIOUS DAY AND LOWER PATIENT RESULTS WERE OBTAINED AFTER RECALIBRATION OF THE ASSAY REAGENT READY PACK. THERE ARE NO DISCORDANT PATIENT SAMPLES AVAILABLE FOR FURTHER TESTING. NO CONCLUSION CAN BE DRAWN. THE INSTRUCTION FOR USE (IFU) UNDER THE RESULTS SECTION STATES THE FOLLOWING: "RESULTS SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH THE PATIENT'S MEDICAL HISTORY, CLINICAL PRESENTATION, AND OTHER FINDINGS." THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    FALSELY ELEVATED ADVIA CENTAUR VITAMIN D RESULTS WERE OBTAINED ON SEVERAL PATIENT SAMPLES AND CONSIDERED DISCORDANT WHEN COMPARED TO LOWER VITAMIN D REPEAT TEST RESULTS. THE CUSTOMER'S QUALITY CONTROL RESULTS HAD SHIFTED HIGH WHEN COMPARED TO THE QUALITY CONTROL RESULT FROM THE PREVIOUS DAY. ONE OF THE FALSELY ELEVATED PATIENT RESULTS WAS QUESTIONED BY THE PHYSICIAN. THE CUSTOMER PERFORMED REPEAT TESTING ON PATIENT SAMPLES RUN THE PREVIOUS DAY AFTER RECALIBRATION OF THE REAGENT READY PACK AND OBTAINING ACCEPTABLE QUALITY CONTROL RESULTS. THE REPEAT RESULTS WERE LOWER AND CORRECTED REPORTS WERE PROVIDED WITHIN A 24 HOUR PERIOD. THERE WAS NO KNOWN REPORT OF PATIENT TREATMENT BEING ALTERED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED VITAMIN D ASSAY RESULTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1