BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPANSE LABORATORY / GENETICS / MICROBIOLOGY / ANATOMICAL PATHOLOGY

    MDR report key: 21388861 · Received February 14, 2025

    Report

    Report Number
    3009404844-2025-00002
    Event Type
    Malfunction
    Date Received
    February 14, 2025
    Report Date
    February 14, 2025
    Manufacturer
    MEDICAL INFORMATION TECHNOLOGY, INC.
    Product Code
    JQP
    Removal / Correction Number
    3009404844-02/14/2025-00
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON JANUARY 22, 2025, A MEDITECH CUSTOMER REPORTED THAT MICROBIOLOGY RESULTS HAD THE POTENTIAL TO BE DELETED FROM AN ENTRY SCREEN. MEDITECH DISCUSSED THE ISSUE WITH THE CUSTOMER AND ATTEMPTED TO REPRODUCE THE ISSUE BUT WERE UNSUCCESSFUL. ON JANUARY 22, 2025, MEDITECH INSTALLED "TRAP CODE" IN THE CUSTOMER'S DIRECTORY TO GATHER MORE INFORMATION ON THE ISSUE. ON JANUARY 23, 2025, MEDITECH WAS ABLE TO REPRODUCE THE ISSUE IN A CONTROLLED, INHOUSE DEVELOPMENT RING. ALTHOUGH THE ISSUE WAS NOT A SOFTWARE MALFUNCTION IN ANY OF THE MEDICAL DEVICES, THE PROBLEM MANIFESTS ITSELF IN THE LABORATORY (LAB), BLOOD BANK (BBK), MICROBIOLOGY (MIC), GENETICS (GEN) AND ANATOMICAL PATHOLOGY (PTH) PRODUCTS. THE ISSUE WAS CONFIRMED TO BE RELATED TO A TECHNICAL CHANGE THAT WAS IMPLEMENTED IN OUR WEB PRESENTATION LAYER WEB CLIENT WHICH CHANGED HOW THE SYSTEM READS KEYSTROKES. AS OPPOSED TO TAKING ACTION WHEN A KEY IS PRESSED DOWN, ACTIONS ARE ALSO BEING TAKEN AS THE KEY IS RELEASED. THE SOFTWARE CORRECTION WAS IDENTIFIED AND FURTHER EXPANSIVE TESTING CONTINUED DUE TO THE BROAD IMPACT OF THIS ISSUE. PRIORITY EVENT CALLS WERE HELD AT MEDITECH ON TUESDAY, JANUARY 28, 2025 AND THURSDAY, JANUARY 30, 2025 TO DISCUSS THE DETAILS OF THE ISSUE AND IMPACT TO OUR MEDICAL DEVICE PRODUCTS, AND ON JANUARY 30, 2025, IT WAS DETERMINED THAT THE ISSUE WAS A PRIORITY 1. A DETAILED REVIEW OF CUSTOMER COMPLAINTS WAS PERFORMED AND SEVERAL ADDITIONAL COMPLAINTS WERE IDENTIFIED. ALL COMPLAINTS RELATED TO THIS MDR ARE ATTACHED TO CORRECTION REPORT 3009404844-02/14/2025-001-C. PRIORITY EVENT NOTIFICATIONS WERE E-MAILED TO THE LAB CUSTOMERS ON FEBRUARY 2, 2025 WITH DETAILS ABOUT THE ISSUE AND ANY AVAILABLE WORKAROUNDS. AFTER RIGOROUS IN-HOUSE TESTING, THE SOFTWARE CORRECTION WAS MADE AVAILABLE FOR DELIVERY TO IMPACTED CUSTOMERS ON FEBRUARY 5, 2025. NO PATIENT HARM HAS BEEN REPORTED AS A RESULT OF THIS ISSUE.

    Description of Event or Problem · 0

    AN ISSUE IS OCCURRING WHEREBY ENTERING MULTIPLE KEYS SIMULTANEOUSLY THAT TRIGGER INPUT MAY REMOVE DATA FROM THE FIRST FIELD OF SCREENS AND/OR QUESTIONNAIRES WITH MORE THAN ONE FIELD. MEDITECH DISCOVERED THE ISSUE MAY OCCUR IN ANY SCREEN WITH TWO OR MORE FIELDS AND IS MOST PREVALENT WITHIN THE RESULT ENTRY SCREEN IN MICROBIOLOGY (MIC). SPECIFICALLY, IF THE TECHNICIAN PRESSES THE SHORT CUT KEYS OF "E" (ENTER RESULTS) OR "G" (GROWTH) AND THE ENTER KEY QUICKLY ON THE MAIN PAGE OF MIC RESULT ENTRY TO MOVE TO ANOTHER RESULTING PAGE, THE DATA IN THE FIRST FIELD MAY BE REMOVED. WHEN THIS OCCURS, IT COULD IMPACT THE FIRST ORGANISM FOR A "CULT" (CULTURE) TYPE PAGE OR THE FIRST PROCEDURE PROMPT RESPONSE FOR A "QUES" (QUESTIONNAIRE) OR "MULT" (MULTIPLE LINE QUESTIONNAIRE) TYPE PAGE. ADDITIONALLY, IN LABORATORY (LAB) AND GENETICS (GEN) RESULT ENTRY, AND PATHOLOGY (PTH) FINDINGS ENTRY, THE RESULTS OF A TEST, COMPONENT, OR QUESTIONNAIRE PROMPT MAY BE DELETED FROM THE SCREEN IF THE TECHNOLOGIST QUICKLY PRESSES ENTER AFTER ENTER/EDITING A RESULT ON THE PRIOR LINE. WHEN THIS OCCURS, RESULT AND/OR ORGANISM DATA COULD BE REMOVED AND NEED TO BE MANUALLY RE-ENTERED. IF A MIC ORGANISM WERE TO BE REMOVED IN AN UNVERIFIED STATE, IT'S POSSIBLE THAT THE SPECIMEN COULD BE FINAL/VERIFIED WITHOUT THE INITIAL ORGANISM THAT WAS IDENTIFIED. IT IS IMPORTANT TO NOTE THERE ARE MULTIPLE FACTORS CONTRIBUTING TO THIS ISSUE OCCURRING INCLUDING: NETWORK SPEED, NUMBER OF USERS ACCESSING THE SYSTEM, AND DEVICE PERFORMANCE. WHEN THIS OCCURS, IT MAY IMPACT LABORATORY, BLOOD BANK, MICROBIOLOGY, GENETICS OR ANATOMICAL PATHOLOGY WHEN CONNECTED VIA THE WEB PRESENTATION LAYER (WPL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1002524 EXPANSE LABORATORY / GENETICS / MICROBIOLOGY / ANATOMICAL PATHOLOGY EXPANSE LABORATORY / GENETICS / MICROBIOLOGY / ANATOMICAL PATHOLOGY JQP MEDICAL INFORMATION TECHNOLOGY, INC. EXPANSE RELEASES 2.1 & 2.2

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown