BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDITECH MIRCOBIOLOGY

    MDR report key: 3834596 · Received January 31, 2014

    Report

    Report Number
    3009404844-2014-00001
    Event Type
    Malfunction
    Date Received
    January 31, 2014
    Report Date
    January 15, 2014
    Manufacturer
    MEDICAL INFORMATION TECHNOLOGY INC.
    Product Code
    OUG
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SOFTWARE CAUSED PRODUCT PROBLEM. DEVICE AVAILABLE FOR EVALUATION: THE MAGIC AND CLIENT SERVER MICROBIOLOGY SOFTWARE AT THE CUSTOMER LOCATION ARE AVAILABLE TO MEDITECH STAFF THROUGH A SECURE VPN CONNECTION. THE CUSTOMER SITE HAS TWO SEPARATE MICROBIOLOGY 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 MICROBIOLOGY DEPARTMENT, MEDITECH MAINTAINS CONTROLLED TESTING ENVIRONMENTS FOR THE CUSTOMER VERSION AS WELL AS FOR ALL VERSIONS OF THE MICROBIOLOGY SOFTWARE. EVALUATION OF MALFUNCTION: AFTER INVESTIGATING THE ISSUE REPORTED BY THE CUSTOMER FOR CLIENT SERVER RELEASE 6.07, MEDITECH PERFORMED ADDITIONAL ON-SITE AND INHOUSE TESTING AND DETERMINED THAT THE SAME ISSUE AFFECTS MULTIPLE RELEASES OF MAGIC AND CLIENT SERVER. INVESTIGATION OF THE SOFTWARE IN MEDITECH'S CONTROLED TESTING ENVIRONMENT FOUND THAT THIS ISSUE CAN OCCUR DUE TO AN EFFORT IN A CHECK PROGRAM THAT LOOKS TO SEE IF THE PROCEDURE PROMPT IS ACTIVE OR NOT BEFORE COMPILING THE PROMPTS/RESULTS FOR PRINTING. THIS ISSUE AFFECTS THE MAGIC MICROBIOLOGY SOFTWARE RELEASES 5.6, 5.64 AND 5.66 AND CLIENT SERVER MICROBIOLOGY SOFTWARE RELEASES 5.6, 5.65, 5.66, 6.0, 6.05, 6.06, 6.07, 6.1 AND 6.13. SOFTWARE CORRECTION: MEDITECH HAS MODIFIED THE SOFTWARE FOR ALL OF THE MAGIC AND CLIENT SERVER RELEASES NOTED ABOVE SO THAT HISTORICAL RESULTS WILL BE RETAINED FOR MICROBIOLOGY PROCEDURE PROMPTS WHEN INACTIVATING A MICROBIOLOGY PROCEDURE PROMPT IN THE MICROBIOLOGY PROCEDURE DICTIONARY. MEDITECH HAS EVALUATED THE DEVICE AFTER CORRECTIONS WERE MADE AND DETERMINED THE SOFTWARE IS WORKING AS INTENDED. THE FOLLOWING WORKAROUND HAS ALSO BEEN PROVIDED: RE-ACTIVATING THE PROCEDURE PROMPT CAUSES THE RESULTS TO BE VISIBLE AGAIN ON ALL AFFECTED SPECIMENS, IN MICROBIOLOGY AND THE EMR. NOTIFICATION AND DISTRIBUTION: BEGINNING ON 01/17/2014, MEDITECH DISTRIBUTED A NOTIFICATION TO CUSTOMERS WHO HAVE MAGIC OR CLIENT SERVER MICROBIOLOGY SOFTWARE PRODUCT IN EITHER TEST OR LIVE FOR THE RELEASES NOTED ABOVE. THIS NOTIFICATION WAS MADE VIA -EMAILED 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 CUSTOMER WHO COULD BE IMPACTED BEGINNING ON (B)(4) 2014.

    Description of Event or Problem · 1

    MICROBIOLOGY PROCEDURE PROMPTS ARE ATTACHED TO MICROBIOLOGY PROCEDURES IN THE MEDITECH MICROBIOLOGY SOFTWARE SYSTEM AND ARE USED TO CAPTURE VARIOUS MICROBIOLOGY RESULTS. ON (B)(6) 2014, A MEDITECH CUSTOMER REPORTED IN THEIR LIVE ENVIRONMENT THAT AFTER CREATING NEW PROCEDURE PROMPTS AND INACTIVATING THE OLD PROCEDURE PROMPTS IN THE MICROBIOLOGY PROCEDURE DICTIONARY, RESULTS FILED ON PREVIOUS SPECIMENS REFERENCING THE OLD PROCEDURE PROMPTS WERE MISSING. THE DATA IS STILL INTACT INTERNALLY ON THE SPECIMENS, BUT NO LONGER VISIBLE EXTERNALLY TO THE END USER. MEDITECH INVESTIGATED THE COMPLAINT AND THE ISSUE WAS REPRODUCED IN MEDITECH'S IN-HOUSE, CONTROLLED TESTING ENVIRONMENT ON (B)(6)2014. NO PATIENTS WERE HARMED DUE TO THIS ISSUE. IF THIS SITUATION WERE TO OCCUR IN A LIVE ENVIRONMENT, AND CERTAIN MICROBIOLOGY RESULTS WERE NO LONGER DISPLAYED FROM CURRENT AND PREVIOUS SPECIMENS (DATA STILL INTACT INTERNALLY), THERE MAY BE A POTENTIAL FOR A DELAY IN PATIENT CARE. PHYSICIANS MAY PRESCRIBE INCORRECT TREATMENT TO PATIENTS BASED ON THE MISSING RESULTS, WHICH COULD LEAD TO PATIENT HARM DUE TO THE SOFTWARE MALFUNCTION. THE WORKAROUND NOTED BELOW WILL IMMEDIATELY CORRECT THIS PROBLEM UNTIL THE AFFECTED CUSTOMERS RECEIVE THE SOFTWARE CORRECTION, MINIMIZING THE POTENTIAL FOR PATIENT HARM. A WORKAROUND IS AVAILABLE: RE-ACTIVATING THE PROCEDURE PROMPT CAUSES THE RESULTS TO BE VISIBLE AGAIN ON ALL AFFECTED SPECIMENS IN MICROBIOLOGY AND THE EMR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68343 MEDITECH MIRCOBIOLOGY OUG MEDICAL INFORMATION TECHNOLOGY INC. MAGIC 5.6., 5.64, 5.66 AND CS 5.6, 5.65, 5.66, 6.0, 6.05, 6.06, 6.07, 6.1, 6.13

    Patients

    Seq Age Sex Outcome Treatment
    1