BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR VANCOMYCIN (VANC) ASSAY

    MDR report key: 3010362 · Received March 19, 2013

    Report

    Report Number
    1219913-2013-00051
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    February 18, 2013
    Report Date
    February 20, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    LEH
    PMA / PMN Number
    K951059
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT ADVIA CENTAUR VANCOMYCIN RESULT IS UNKNOWN. QUALITY CONTROLS ARE WITHIN RANGE. NO CONCLUSION CAN BE DRAWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATION. THE IFU IN THE EXPECTED RESULTS SECTION: "AS WITH ALL THERAPEUTIC AGENTS, VANCOMYCIN CONCENTRATIONS MUST BE EVALUATED IN CONJUNCTION WITH THE COMPLETE CLINICAL PROFILE TO PROVIDE EFFECTIVE THERAPY."

    Description of Event or Problem · 1

    A FALSELY ELEVATED ADVIA CENTAUR VANCOMYCIN RESULT WAS OBTAINED ON A PATIENT SAMPLE AND THE RESULT WAS CONSIDERED DISCORDANT WHEN COMPARED WITH REPEAT SAMPLE TESTING. THERE WAS NO REPORT OF PATIENT TREATMENT BEING PRESCRIBED OR ALTERED AND THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR VANCOMYCIN RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114373 ADVIA CENTAUR VANCOMYCIN (VANC) ASSAY VANCOMYCIN IMMUNOASSAY LEH SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 017194

    Patients

    Seq Age Sex Outcome Treatment
    1