BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDITECH BLOOD BANK SOFTWARE

    MDR report key: 2370356 · Received July 28, 2011

    Report

    Report Number
    1222805-2011-00004
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    June 29, 2011
    Report Date
    July 25, 2011
    Manufacturer
    MEDICAL INFORMATION TECHNOLOGY, INC.
    Product Code
    MMH
    PMA / PMN Number
    BK060029
    Removal / Correction Number
    1222805-07/06/11-004-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE AVAILABLE FOR EVALUATION: THE BLOOD BANK SOFTWARE AND DATABASE AT THE CUSTOMER LOCATION IS AVAILABLE TO (B)(4) STAFF THROUGH A SECURE VPN CONNECTION. THE CUSTOMER SITE HAS TWO SEPARATE DATABASES WITH THE SAME VERSION OF SOFTWARE: A TEST DATABASE USED FOR RESEARCH, TESTING, AND VERIFICATION; AND A LIVE DATABASE USED FOR RECORDING THE DAILY OPERATIONS OF THE HOSPITAL'S BLOOD BANK. MEDITECH MAINTAINS CONTROLLED TESTING ENVIRONMENTS FOR THE CUSTOMER VERSION AS WELL AS FOR ALL VERSIONS OF BLOOD BANK STANDARD SOFTWARE. EVALUATION OF MALFUNCTION: INVESTIGATION OF THE SOFTWARE IN THE HOSPITAL'S TEST DATABASE AND IN MEDITECH'S CONTROLLED TESTING ENVIRONMENT FOUND THAT THE MALFUNCTION RESULTED IN A UNIT WITH A POSITIVE ANTIBODY SCREEN WITHOUT AN ANTIBODY IDENTIFICATION. THE ERROR ONLY OCCURS WHEN USING THE INSTRUMENT TO RESULT ANTIBODY SCREENS AND THE BLOOD BANK SOFTWARE VERSION IS MAGIC RELEASE 5.63 OR HIGHER. SOFTWARE CORRECTION: MEDITECH HAS MODIFIED THE SOFTWARE FOR MAGIC RELEASE 5.63 AND HIGHER TO ENSURE THAT THE APPROPRIATE REFLEX ORDERS ARE ADDED BASED OFF OF THE ANTIBODY SCREEN INTERPRETATION RESULTS IN ALL CASES. (B)(4) HAS EVALUATED THE DEVICE AFTER CORRECTIONS WERE MADE AND DETERMINED THE SOFTWARE IS WORKING AS INTENDED. THE FOLLOWING WORKAROUND HAS ALSO BEEN PROVIDED: IN THE ANALYZER RESULT TRANSMISSION SCREEN, IF THE USER NOTICES THAT THE REFLEX HAS NOT BEEN AUTOMATICALLY EVALUATED, THEY CAN MANUALLY ADD ON THE ANTIBODY IDENTIFICATION TEST. NOTIFICATION AND DISTRIBUTION: BEGINNING ON (B)(4) 2011 (B)(4) DISTRIBUTED A NOTIFICATION TO CUSTOMERS WHO ARE LIVE WITH MEDITECH MAGIC BLOOD BANK RELEASE 5.63 AND HIGHER. THIS NOTIFICATION WAS MADE VIA E-MAILED TASK UPDATES THAT CAN BE PRINTED BY THE CUSTOMER. TASK UPDATES SENT VIA E-MAIL ARE IMMEDIATELY TRANSMITTED TO THE CUSTOMER. CODE CHANGES ARE BEING PROVIDED TO ALL CUSTOMERS WHO COULD BE IMPACTED BEGINNING ON (B)(4) 2011. (B)(4) HAS NOTIFIED ALL BLOOD BANK CUSTOMERS USING AN INTERFACE WITH A BBK INSTRUMENT THAT IS CAPABLE OF RUNNING ANTIBODY SCREENS. CODE CHANGES ARE BEING PROVIDED TO ALL CUSTOMERS USING SUCH INSTRUMENTATION. THE FOLLOWING ATTACHMENTS HAVE ALSO BEEN PROVIDED: CORRECTION REPORT 1222805-07/06/11-004-C, DEVICE LABELING, LIST OF AFFECTED CONSIGNEES, EXAMPLE OF NOTIFICATION PROVIDED TO CONSIGNEES, CUSTOMER COMPLAINTS RELATED TO THE CORRECTION, HEALTH HAZARD EVALUATION, CAPA REPORT (B)(4).

    Description of Event or Problem · 1

    DATE OF COMPLAINT: THE ISSUE WAS IDENTIFIED BY A CUSTOMER WHILE TESTING A SOFTWARE UPDATE IN THEIR TEST SYSTEM AND WAS CONFIRMED TO BE A POTENTIAL PATIENT SAFETY ISSUE BY (B)(4) ON (B)(6) 2011. DESCRIPTION OF COMPLAINT: WHEN ANTIBODY SCREEN INTERPRETATION RESULTS ARE SENT VIA AN INSTRUMENT INTERFACE, REFLEX ORDERS (A METHOD TO AUTOMATICALLY TRIGGER ANOTHER ORDER UNDER USER-DEFINED CRITERIA) BASED OFF OF THIS INTERPRETATION RESULT ARE NOT TRIGGERING APPROPRIATELY. IN THE MOST SEVERE OF CASES, THIS MEANS THAT POTENTIALLY A POSITIVE ANTIBODY SCREEN WOULD NOT HAVE AN ANTIBODY IDENTIFICATION TEST PERFORMED, WHEN ATTACHED AS A REFLEX ORDER TO THE ANTIBODY SCREEN TEST. IN THE APPROPRIATE REFLEX OF AN ANTIBODY IDENTIFICATION TEST IS NOT AUTOMATICALLY TRIGGERED FROM A POSITIVE ANTIBODY SCREEN, THIS COULD POSSIBLY RESULT IN THOSE ANTIBODIES NEVER BEING IDENTIFIED. THIS COULD POTENTIALLY LEAD TO AN UNSUITABLE UNIT BEING TRANSFUSED TO A PATIENT, AND MAY CAUSE A TRANSFUSION REACTION. THIS ISSUE EXISTS ONLY FOR THOSE CUSTOMERS THAT ARE FILING ANTIBODY SCREEN INTERPRETATION RESULTS DIRECTLY FROM AN INSTRUMENT INTERFACE. THOSE CUSTOMERS THAT ARE NOT USING THEIR INTERFACE TO FILE ANTIBODY SCREEN RESULTS WOULD NOT BE AFFECTED. WHEN THE USER ENTERS ANTIBODY SCREEN RESULTS MANUALLY, THE APPROPRIATE REFLEX ORDERS ARE TRIGGERED BASED ON THE ANTIBODY SCREEN INTERPRETATION RESULTS. THERE WERE NO REPORTED INJURIES FROM THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDITECH BLOOD BANK SOFTWARE MEDITECH BLOOD BANK, PRODUCT CODE: MMH MMH MEDICAL INFORMATION TECHNOLOGY, INC. MAGIC 5.63, 5.64

    Patients

    Seq Age Sex Outcome Treatment
    1