BEUDAMED
    FDA Adverse Event Other Summary report: N

    DCA VANTAGE ANALYZER

    MDR report key: 3159172 · Received June 4, 2013

    Report

    Report Number
    1217157-2013-00088
    Event Type
    Other
    Date Received
    June 4, 2013
    Date of Event
    April 29, 2013
    Report Date
    May 15, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    CGX
    PMA / PMN Number
    K071466
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT HBA1C RESULT IS UNKNOWN.

    Description of Event or Problem · 1

    CUSTOMER REPORTED DISCORDANT HEMOGLOBIN ALC (HBA1C) RESULTS. A FINGER STICK ON THE DCA RESULTED IN A HBA1C OF 12.2% WHEREAS A VENIPUNCTURE REFERENCE LAB HBA1C RESULT WAS 8.8%. THERE WAS NO REPORT OF INJURY FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247390 DCA VANTAGE ANALYZER DCA VANTAGE CGX SIEMENS HEALTHCARE DIAGNOSTICS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1