BEUDAMED
    FDA Adverse Event Other Summary report: N

    DCA VANTAGE

    MDR report key: 3001502 · Received March 6, 2013

    Report

    Report Number
    1217157-2013-00030
    Event Type
    Other
    Date Received
    March 6, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 12, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    CGX
    PMA / PMN Number
    K071466
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THIS DISCORDANT IS UNK.

    Description of Event or Problem · 1

    CUSTOMER REPORTS DISCREPANT LOW HBA1C RESULTS ON THE DCA VANTAGE VS A REFERENCE METHOD AND HISTORICAL DATA. MEDICATION (METFORMIN) DOSE WAS ADJUSTED BASED ON THE LOWER HBA1C RESULT. ORIGINAL DOSE = 1000 MG METFORMIN; ADJUSTED DOSE = 500 METFORMIN. THERE WAS NO REPORT OF INJURY FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96060 DCA VANTAGE DCA VANTAGE CGX SIEMENS HEALTHCARE DIAGNOSTICS VANTAGE

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR