BEUDAMED
    FDA Adverse Event Other Summary report: N

    DCA VANTAGE

    MDR report key: 2987959 · Received February 25, 2013

    Report

    Report Number
    1217157-2013-00025
    Event Type
    Other
    Date Received
    February 25, 2013
    Date of Event
    January 28, 2013
    Report Date
    January 28, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    CGX
    PMA / PMN Number
    K071466
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT HBALC RESULT IS UNK.

    Description of Event or Problem · 1

    A HBALC RESULT WAS HIGHER ON THE DCA VANTAGE WHEN COMPARED TO ANOTHER REFERENCE METHOD. THERE WAS NO IMPACT TO PT CARE AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79232 DCA VANTAGE DCA VANTAGE CGX SIEMENS HEALTHCARE DIAGNOSTICS VANTAGE

    Patients

    Seq Age Sex Outcome Treatment
    1