BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DCA VANTAGE

    MDR report key: 4210424 · Received October 29, 2014

    Report

    Report Number
    1217157-2014-00164
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    September 29, 2014
    Report Date
    October 2, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    LCP
    PMA / PMN Number
    K071466
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER STATED THAT ALL IS WORKING WELL AFTER TRAINING AND DOES NOT REQUIRE ANY FOLLOW UP CONTACT.CUSTOMER RECEIVED AN EXCHANGE INSTRUMENT FOR CUSTOMER SATISFACTION, AND IS OPERATIONAL AFTER HAVING BEEN RE-TRAINED.

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT HEMOGLOBIN (B)(6) RESULTS IS UNKNOWN.

    Description of Event or Problem · 1

    CUSTOMER REPORTED DISCORDANT HEMOGLOBIN ((B)(6)) RESULTS ON THE INSTRUMENT. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692487 DCA VANTAGE DCA LCP SIEMENS HEALTHCARE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1