BEUDAMED
    FDA Adverse Event Other Summary report: N

    DCA VANTAGE ANALYZER

    MDR report key: 3071042 · Received April 11, 2013

    Report

    Report Number
    1217157-2013-00059
    Event Type
    Other
    Date Received
    April 11, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 28, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    CGX
    PMA / PMN Number
    K071466
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, 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 HIGH HEMOGLOBIN A1C RESULTS. CUSTOMER REPORTED THAT ON (B)(6) 2013, HEMOGLOBIN A1C MEASURED 9.3 ON A CAPILLARY SAMPLE BUT IT READ APPROXIMATELY 2 POINTS LOWER FROM TESTING AT A REFERRAL LAB. THERE WAS NO REPORT OR INJURY FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155729 DCA VANTAGE ANALYZER DCA CGX SIEMENS HEALTHCARE DIAGNOSTICS INC. 6044122

    Patients

    Seq Age Sex Outcome Treatment
    1