BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EQUE

    MDR report key: 920828 · Received September 27, 2007

    Report

    Report Number
    3000237768-2007-00001
    Event Type
    Malfunction
    Date Received
    September 27, 2007
    Date of Event
    August 28, 2007
    Report Date
    September 27, 2007
    Manufacturer
    5D INFORMATION MANAGEMENT
    Product Code
    MMH
    PMA / PMN Number
    BK050060
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SOFTWARE IS CONFIGURABLE BY THE BLOOD CENTER. THE SOFTWARE FLAGS ANSWERS TO QUESTIONS FROM DONORS THAT REQUIRE FOLLOW UP BY THE BLOOD CENTER SCREENER. UNDER CERTAIN CONFIGURATIONS, THE FLAGS ARE NOT VISIBLE TO THE SCREENER.

    Description of Event or Problem · 1

    AN ANOMALY IN A BLOOD DONOR SELF-ADMINISTERED QUESTIONNAIRE SOFTWARE APPLICATION MAY, UNDER CERTAIN CIRCUMSTANCES, ALLOW A DONOR TO BE QUALIFIED TO DONATE WHEN IN FACT THAT DONOR SHOULD BE DEFERRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EQUE BLOOD ESTABLISHMENT COMPUTER SOFTWARE MMH 5D INFORMATION MANAGEMENT VERSION 1.2.1

    Patients

    Seq Age Sex Outcome Treatment
    1 YR