BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDITECH CLIENT SERVER MICROBIOLOGY

    MDR report key: 3678918 · Received February 20, 2014

    Report

    Report Number
    3009404844-2014-00002
    Event Type
    Malfunction
    Date Received
    February 20, 2014
    Report Date
    February 14, 2014
    Manufacturer
    MEDICAL INFORMATION TECHNOLOGY INC.
    Product Code
    OUG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: SOFTWARE CAUSED PRODUCT PROBLEM. DEVICE AVAILABLE FOR EVALUATION: THE CLIENT SERVER MICROBIOLOGY SOFTWARE AT THE CUSTOMER LOCATION IS 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 VERSION 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 IN-HOUSE TESTING AND DETERMINED THAT THE SAME ISSUE AFFECTS MULTIPLE CLIENT SERVER RELEASES. INVESTIGATION OF THE SOFTWARE IN MEDITECH'S CONTROLLED TESTING ENVIRONMENT FOUND THAT THIS ISSUE CAN OCCUR DUE TO AN OMISSION IN DESIGN WHICH DOES NOT ACCOUNT FOR ISOLATED ORGANISM BEING RECEIVED VIA A MEDINET INTERFACE IN INTEGER FORMAT. THE WORKAROUND NOTED WILL IMMEDIATELY MITIGATE THE MALFUNCTION UNTIL THE AFFECTED CUSTOMERS RECEIVE THE SOFTWARE CORRECTION, REDUCING THE POTENTIAL FOR PATIENT HARM. THE THIRD PARTY SYSTEM WHERE THE RESULTS ARE SENT VIA THE MEDINET INTERFACE MUST BE CONFIGURED TO IDENTIFY ISOLATES IN A DECIMAL, RATHER THAN INTEGER FORMAT. THIS ISSUE AFFECTS CLIENT SERVER RELEASES 5.6, 5.65, 5.66, 5.67, 6.0, 6.06, 6.07, 6.1, 6.13 AND 6.14. SOFTWARE CORRECTION: MEDITECH HAS CORRECTED THE MALFUNCTION IN CLIENT SERVER RELEASED 5.6, 5.65, 5.66, 5.67, 6.0, 6.06, 6.07, 6.1, 6.13 AND 6.14. MEDITECH HAS EVALUATED THE DEVICE AFTER CORRECTIONS WERE MADE AND DETERMINED THE SOFTWARE IS WORKING AS INTENDED. NOTIFICATION AND DISTRIBUTION: BEGINNING ON FEBRUARY 3, 2014 MEDITECH DISTRIBUTED A NOTIFICATION TO CUSTOMERS WHO HAVE THE CLIENT SERVER MICROBIOLOGY SOFTWARE PRODUCT IN EITHER TEST OR LIVE FOR THE RELEASES NOTED ABOVE. 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 AFTER THE SOFTWARE CORRECTION IS PRODUCTION TESTED IN-HOUSE WITH NO ADDITIONAL ISSUES IDENTIFIED.

    Description of Event or Problem · 1

    MICROBIOLOGY TESTING ON SAMPLES IS PERFORMED EITHER IN THE LABORATORY WHERE THE SPECIMEN WAS COLLECTED OR AT AN OFF-SITE REFERENCE LABORATORY. RESULTS OF TESTING PERFORMED ON AN AUTOMATED INSTRUMENT OR AT A REFERENCE LABORATORY MAY BE SENT TO THE ORDERING SYSTEM VIA AN INTERFACE. ON (B)(6) 2013, A MEDITECH CUSTOMER REPORTED THAT AN ORGANISM WHICH HAD BEEN PREVIOUSLY ISOLATED ON A SPECIMEN HAD BEEN COMPLETED REPLACED BY A SUBSEQUENTLY ISOLATED ORGANISM WHEN THE SECOND ISOLATE WAS RECEIVED VIA A MEDINET INTERFACE. AFTER WORKING CLOSELY WITH THE CUSTOMER AND INVESTIGATING THE ISSUE, MEDITECH WAS ABLE TO REPRODUCE THE ISSUE IN MEDITECH'S IN-HOUSE, CONTROLLED TESTING ENVIRONMENT ON (B)(4) 2014. A CODING SOLUTION WAS CREATED AND IS BEING PROVIDED TO ALL AFFECTED CUSTOMERS. NO PATIENT HARM HAS BEEN REPORTED DUE TO THIS ISSUE. IF THIS SITUATION WERE TO OCCUR IN A LIVE ENVIRONMENT, PHYSICIANS MAY BE PRESENTED WITH INCOMPLETE ISOLATE INFORMATION AND ERRONEOUS ANTIMICROBIAL SUSCEPTIBILITY TESTING RESULTS IN THE EHR. PHYSICIAN COMBINE RESULTS OF ANTIMICROBIAL SUSCEPTIBILITY TESTING WITH CLINICAL INFORMATION AND EXPERIENCE TO SELECT THE MOST APPROPRIATE ANTIBIOTIC FOR THEIR PATIENT. THE WORKAROUND WILL IMMEDIATELY MITIGATE THIS PROBLEM UNTIL THE AFFECTED CUSTOMERS RECEIVE THE SOFTWARE CORRECTION, MINIMIZING THE POTENTIAL FOR PATIENT HARM. THE THIRD PARTY SYSTEM WHERE THE RESULTS ARE SENT VIA THE MEDINET INTERFACE MUST BE CONFIGURED TO IDENTIFY ISOLATES IN A DECIMAL, RATHER THAN INTEGER FORMAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106819 MEDITECH CLIENT SERVER MICROBIOLOGY MEDITECH MICROBIOLOGY OUG MEDICAL INFORMATION TECHNOLOGY INC. CLIENT SERVER RELEASES 5.6, 5.65, 5.66, 6.0, 6.05, 6.07, 6.1, 6.13 AND 6.14

    Patients

    Seq Age Sex Outcome Treatment
    1