BEUDAMED
    FDA Adverse Event Other Summary report: N

    DCA VANTAGE

    MDR report key: 2938049 · Received January 25, 2013

    Report

    Report Number
    1217157-2012-00084
    Event Type
    Other
    Date Received
    January 25, 2013
    Date of Event
    December 18, 2012
    Report Date
    December 18, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    CGX
    PMA / PMN Number
    K071466
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING METHOD OF REFERENCE LAB WAS NOT REPORTED. CUSTOMER WAS TOLD QUALITY CONTROL MEASURES SHOULD BE RUN AT THE SAME TIME AS PT TESTING. CUSTOMER REPORTS THAT CURRENTLY QUALITY CONTROL IS BEING PERFORMED BUT, NOT BY THE TECHNICIAN PERFORMING THE TEST. CUSTOMER FURTHER ADVISED THAT QUALITY CONTROL SHOULD BE RUN WITH NEW LOTS OF CASSETTES. CUSTOMER STATES THAT CURRENTLY QUALITY CONTROL IS BEING RUN ONLY AT 90 DAY INTERVALS IF TIME PERMITS. IN ADDITION CUSTOMER WAS ADVISED TO PERFORM A PT CORRELATION WITH THE REFERENCE LAB USED.

    Description of Event or Problem · 1

    CUSTOMER REPORTS A DISCORDANT (B)(6) RESULT. PHYSICIAN QUESTIONED RESULT AND REQUESTED A SAMPLE SENT TO REFERENCE LAB FOR COMPARISON. NO REPORT OF INJURY WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35495 DCA VANTAGE DCA VANTAGE CGX SIEMENS HEALTHCARE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1