BEUDAMED
    FDA Adverse Event Other Summary report: N

    DCA VANTAGE

    MDR report key: 2913620 · Received January 7, 2013

    Report

    Report Number
    1217157-2012-00075
    Event Type
    Other
    Date Received
    January 7, 2013
    Date of Event
    November 27, 2012
    Report Date
    November 27, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    CGX
    PMA / PMN Number
    K071466
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER WILL IDENTIFY REFERENCE METHOD USED BY (B)(6). MFR INVESTIGATING.

    Description of Event or Problem · 1

    CUSTOMER REPORTS DISCORDANT HBA1C RESULTS ON TWO KNOWN DIABETIC PTS. PT 1: PT PRESENTS AS (B)(6) KNOWN DIABETIC. DIABETES TREATED WITH STARLIX (NATEGLINIDE). PT HAD A RESULT OF 6.0% ON THE DCA VANTAGE VIA FINGERSTICK, STATES HE HAD A1C PERFORMED BY (B)(6) ON (B)(6) 2012 VIA VENIPUNCTURE, RESULT OF 7.7%. RESULT OF 6.0% AND 7.7% WERE GIVEN TO THE PHYSICIAN, UNK IF ACTION WAS TAKEN ON EITHER RESULT. OTHER MEDICATIONS INCLUDE LIPITOR, DIOVAN, CLONIDINE AND ATENOLOL. PREVIOUS A1C RESULTS: (B)(6) 2012: 6.3% (REFERENCE LAB). (B)(6) 2012: 5.6% (REFERENCE LAB).

    Additional Manufacturer Narrative · 2

    CUSTOMER WILL IDENTIFY REFERENCE METHOD USED BY (B)(6). MFR INVESTIGATING.

    Description of Event or Problem · 2

    CUSTOMER REPORTS DISCORDANT HBA1C RESULTS ON TWO KNOWN DIABETIC PTS. PT 2: PT 2 PRESENTS AS A KNOWN DIABETIC FEMALE, AGE UNK, WEIGHT UNK. NOT PREGNANT. RESULT OF 6.0% ON DCA VANTAGE, REFERENCE RESULT OF 8.1%. REFERENCE METHODOLOGY UNK. MEDICATION UNK. NO HISTORICAL RESULTS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8409 DCA VANTAGE DCA VANTAGE CGX SIEMENS HEALTHCARE DIAGNOSTICS VANTAGE

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR
    2 UNK