BEUDAMED
    FDA Adverse Event Other Summary report: N

    DCA VANTAGE

    MDR report key: 2997532 · Received March 4, 2013

    Report

    Report Number
    1217157-2013-00023
    Event Type
    Other
    Date Received
    March 4, 2013
    Date of Event
    January 1, 2013
    Report Date
    February 1, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    CGX
    PMA / PMN Number
    K071466
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THIS DISCORDANT HBA1C RESULT IS UNK.

    Description of Event or Problem · 1

    DISCORDANT HIGH HBA1C RESULT WERE REPORTED WHEN COMPARED TO A REFERENCE METHOD. THERE WAS NO IMPACT TO PATIENT CARE AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91477 DCA VANTAGE DCA VANTAGE CGX SIEMENS HEALTHCARE DIAGNOSTICS VANTAGE

    Patients

    Seq Age Sex Outcome Treatment
    1