BEUDAMED
    FDA Adverse Event Other Summary report: N

    DCA VANTAGE

    MDR report key: 2938048 · Received January 25, 2013

    Report

    Report Number
    1217157-2012-00085
    Event Type
    Other
    Date Received
    January 25, 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 STATES SHE SCANNED THE CALIBRATION CARD SUCCESSFULLY AND SYSTEM DISPLAYED THE CORRECT LOT AND EXPIRATION DATE ON THE SCREEN (LOT 0595, EXP 07/2014). TECHNICIAN REALIZED SHE HAD FORGOTTEN TO PRINT IT. SHE PROCEEDED INTO RECALL RESULTS AND ONLY ONE LOT NUMBER WAS LISTED (0595). THE EXPIRATION DATE FOR THE LOT NOW LISTED AS ONE MONTH LATER (08/2014) THAN THE ACTUAL EXPIRATION DATE. CUSTOMER EXITED TO THE HOME SCREEN AND RESCANNED THE CALIBRATION CARD. IT DISPLAYED ON THE SCREEN WITH EXP 07/2014, THE CORRECT DATE. SHE RECALLED THE RESULT, THERE WAS STILL ONLY ONE LOT IN THE CALIBRATION MEMORY AND THE DATE WAS LISTED AS 08/2014, ONE MONTH LATER THAN THE ACTUAL EXPIRATION DATE. MANUFACTURER IS INVESTIGATING.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THAT THE CALIBRATION CARD'S EXPIRATION DATE IS DIFFERENT ON THE CARD VS. THE INSTRUMENT'S MEMORY. NO REPORT OF INJURY WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36343 DCA VANTAGE DCA VANTAGE CGX SIEMENS HEALTHCARE DIAGNOSTICS VANTAGE

    Patients

    Seq Age Sex Outcome Treatment
    1