BEUDAMED
    FDA Adverse Event Other Summary report: N

    DCA VANTAGE ANALYZER

    MDR report key: 3608252 · Received January 23, 2014

    Report

    Report Number
    1217157-2013-00263
    Event Type
    Other
    Date Received
    January 23, 2014
    Date of Event
    December 27, 2013
    Report Date
    December 27, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    CGX
    PMA / PMN Number
    K071466
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER IS BEING INSTRUCTED TO USE CORRECT SAMPLE TECHNIQUE AND ADVISED TO RUN PRECIOUS STUDY. CUSTOMER RAN PRECISION STUDY AND RESULTS WERE IN RANGE. THE EVENT HAS OCCURRED DUE TO AN OPERATOR ERROR. INSTRUMENT IS PERFORMING AS INTENDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED DISCORDANT HEMOGLOBIN A1C (HBA1C) RESULTS ON THE INSTRUMENT. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54683 DCA VANTAGE ANALYZER DCA CGX SIEMENS HEALTHCARE DIAGNOSTICS INC

    Patients

    Seq Age Sex Outcome Treatment
    1