BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EQUE

    MDR report key: 2245846 · Received August 3, 2011

    Report

    Report Number
    3000237768-2011-00001
    Event Type
    Malfunction
    Date Received
    August 3, 2011
    Date of Event
    June 27, 2011
    Report Date
    July 20, 2011
    Manufacturer
    FIFTH DIMENSION INFORMATION SYSTEMS
    Product Code
    MMH
    PMA / PMN Number
    BK050060
    Removal / Correction Number
    3000237768-07/08/11-001-
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE METHOD OF EVAL INCLUDED A DESIGN REVIEW. DEVICE EVAL: THE ISSUE WAS INVESTIGATED AND IT WAS DETERMINED THAT THE SOFTWARE DID NOT CONTAIN THE LOGIC TO HANDLE THE SCENARIO OF AN OVERDUE REVIEW BECAUSE THE REQUIREMENT FOR THE SCENARIO WAS NOT IDENTIFIED AS PART OF THE PRODUCT DEVELOPMENT: WHEN AN OVERDUE REVIEW TRIGGERS A PHYSICAL, THE LONG FORM QUESTIONNAIRE MUST BE PRESENTED TO THE DONOR.

    Description of Event or Problem · 1

    AN ISSUE HAS BEEN IDENTIFIED WITH THE EQUE INTERFACE. THIS ISSUE MAY INCORRECTLY PRESENT DONORS WITH THE SHORT ABBREVIATED FORM QUESTIONNAIRE INSTEAD OF THE MORE DETAILED LONG FORM QUESTIONNAIRE UNDER THE SCENARIO LISTED BELOW. THE SCENARIO: WHEN A DONOR IS CHECKED IN AND REGISTERED IN THE PLASMA CENTER COMPUTER SYSTEM VIA THE EQUE INTERFACE AND THAT DONOR HAS AN OVERDUE REVIEW (E.G. SPE) WHICH COULD NECESSITATE A PHYSICAL EXAM BE PERFORMED BEFORE THE DONOR IS PERMITTED TO DONATE, EQUE MAY PRESENT THE SHORT FORM QUESTIONNAIRE TO THE DONOR INSTEAD OF THE MORE DETAILED LONG FORM QUESTIONNAIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EQUE DONOR SELF ADMINISTERED INTERVIEW SW MMH FIFTH DIMENSION INFORMATION SYSTEMS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1