BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BBCS MOBILE APPLICATION

    MDR report key: 1861240 · Received October 1, 2010

    Report

    Report Number
    3028885-2010-00001
    Event Type
    Malfunction
    Date Received
    October 1, 2010
    Report Date
    September 30, 2010
    Manufacturer
    BLOOD BANK COMPUTER SYSTEMS, INC.
    Product Code
    MMH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L LOT#S: 5.1M, 5.1.1M. THE RISK MITIGATION HAS BEEN REPAIRED BY: CONFIRMATION WITH ALL CLIENTS THAT THEY HAVE RECEIVED THE NOTIFICATION OF THE PRODUCT FAILURE. CONFIRMING WITH ALL CLIENTS THAT THEY HAVE RECEIVED THREE CLEARLY DEFINED CONFIGURATION OPTIONS THAT WILL REPAIR THE MITIGATION. REPAIR OPTION TITLES: ELIMINATE THE INTERACTIVE PORTION OF THE MOBILE UPLOAD PROCESS; RETAIN THE INTERACTIVE PORTION OF THE MOBILE UPLOAD PROCESS - REGISTER ALL NEW DONORS AS NEW; RETAIN THE INTERACTIVE PORTION OF THE MOBILE UPLOAD PROCESS - CONTINUE MATCHING NEW DONORS TO EXISTING DONORS. THE DETAILS AS TO HOW TO CONFIGURE THE DEVICE FOR EACH OPTION HAVE BEEN DISTRIBUTED TO EACH CLIENT. EVAL SUMMARY: DEVICE - BBCS HAS EVALUATED THE DEVICE AND DETERMINED THAT THE PROGRAM IS NOT WORKING AS DESIGNED AND REQUIRES MODIFICATIONS WHICH WILL OCCUR WITH THE NEXT RELEASE OF THE PROGRAM. ALL CLIENTS HAVE BEEN PROVIDED WORKAROUNDS THAT FULLY MITIGATE THE IDENTIFIED RISK. LABELING: THE LABELING OF THE DEVICE IS ACCURATE AND WRITTEN TO CURRENT SPECS.

    Description of Event or Problem · 1

    IT HAS BEEN DETERMINED THAT AN ERROR EXISTS IN THE RISK MITIGATION FOR THE FOLLOWING CAUSE: RECIPIENT HARMED BY UNSUITABLE UNIT (RHZM01). MITIGATION IS LOST WHEN DATA FROM THE MOBILE APPLICATION IS MERGED INTO THE PRIMARY DATABASE WHEN THE FOLLOWING CONDITION OCCURS: THE APPLICATION IS CONFIGURED TO ALLOW THE BLOOD CENTER STAFF TO MANUALLY MATCH DONORS IDENTIFIED IN ERROR AS NEW IN THE FIELD TO DONORS ALREADY EXISTING IN THE PRIMARY DATABASE. THE USER IS NOT BEING CORRECTLY NOTIFIED WHEN THE DONOR IS CURRENTLY DEFERRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BBCS MOBILE APPLICATION BLOOD BANK SOFTWARE MMH BLOOD BANK COMPUTER SYSTEMS, INC. 5.0M

    Patients

    Seq Age Sex Outcome Treatment
    1