BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPANSE LABORATORY / GENETICS / MICROBIOLOGY AND ANATOMICAL PATHOLOGY

    MDR report key: 23391290 · Received October 27, 2025

    Report

    Report Number
    3009404844-2025-00004
    Event Type
    Injury
    Date Received
    October 27, 2025
    Date of Event
    May 12, 2025
    Report Date
    October 27, 2025
    Manufacturer
    MEDICAL INFORMATION TECHNOLOGY, INC.
    Product Code
    JQP
    UDI-DI
    00863529000155
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MEDITECH RESOLUTION AND RECOMMENDATION. MEDITECH'S INVESTIGATION CONFIRMED THE CAUSE OF THE BLANK PAGES AS USER ERROR AND CATEGORIZED THE ADVERSE EVENT OUTCOME AS EDUCATION. MEDITECH STRONGLY RECOMMENDED THAT THE CUSTOMER USE THE "IMAGE DATA SECTION" TO INSERT OUTSIDE VENDOR (OV) REPORTS, RATHER THAN COPY/PASTE WITHIN MICROSOFT WORD, TO PREVENT THE INSERTION OF UNINTENDED BLANK PAGES AND ENSURE THAT IMAGES ARE PERMANENTLY STORED WITHIN THE MEDITECH SOFTWARE. THE CUSTOMER AGREED TO REVIEW AND DISCUSS THIS UPDATED WORKFLOW WITH THE PATHOLOGISTS. MEDITECH MAKES REFERENCE MATERIALS AVAILABLE TO ALL EXPANSE ANATOMICAL PATHOLOGY CUSTOMERS, INCLUDING KNOWLEDGE BASE ARTICLES (KBS) AND TRAINING REFERENCE GUIDES RELATED TO PATHOLOGY DATA SECTIONS, THE PATHOLOGY DICTIONARY OVERVIEW, AND MS WORD REPORT BUILDING. FURTHERMORE, MEDITECH CONFIRMED THAT A NEW SAFETY WORKFLOW/EDUCATION KNOWLEDGE BASE ARTICLE WILL BE CREATED TO ENSURE ALL CUSTOMERS ARE INFORMED ON HOW TO MANAGE SIMILAR SITUATIONS AND POTENTIAL ADVERSE EVENTS.

    Description of Event or Problem · 0

    THE REPORTED ADVERSE EVENT (AE) ORIGINATED AT (B)(6) AND CENTERED ON A PRODUCT USE ERROR THAT RESULTED IN A FIVE-MONTH DELAY IN A PATIENT'S LYMPHOMA DIAGNOSIS AND SUBSEQUENT REFERRAL TO MEDICAL ONCOLOGY. THE DELAY OCCURRED BECAUSE A PROVIDER MISSED CRITICAL DIAGNOSTIC INFORMATION. THE PATIENT, A 73-YEAR-OLD, HAD A LEFT BREAST MASTECTOMY ON (B)(6) 2025. THE PROBLEM THE CORE ISSUE WAS CONFUSION CAUSED BY BLANK PAGES IN AN OUTSIDE VENDOR (OV) PATHOLOGY REPORT (FROM (B)(6) CLINIC) THAT HAD BEEN IMPROPERLY COPIED INTO THE MEDICAL INFORMATION TECHNOLOGY, INC. (MEDITECH) ANATOMICAL PATHOLOGY (PTH) REPORT. IMPROPER WORKFLOW ON (B)(6) 2025, WHEN THE OV RESULTS WERE ENTERED, THE PROVIDER ATTACHED THE OV REPORT TO THE MEDITECH ANATOMICAL PATHOLOGY SPECIMEN REPORT BY TAKING A SCREENSHOT AND USING THE COPY/PASTE FUNCTION IN MICROSOFT WORD. RESULTING BLANK PAGES THIS FLAWED WORKFLOW RESULTED IN TWO PRIMARILY BLANK PAGES BEING INSERTED BETWEEN PAGES 1 AND 3 OF THE MAYO CLINIC PATHOLOGY REPORT WITHIN THE MEDITECH SYSTEM. THESE BLANK PAGES LATER CAUSED CONFUSION DURING CHART REVIEW. MISSED DIAGNOSIS THE PROVIDER REVIEWED ONLY THE FIRST PAGE, WHICH DISPLAYED A "RESULT SUMMARY" OF "NEGATIVE" FOR B-CELL LYMPHOMA, FISH, TISSUE RESULTS. BECAUSE THE SUBSEQUENT PAGES APPEARED BLANK, THE PROVIDER DID NOT CONTINUE REVIEWING THE REPORT. THE CRITICAL FINAL DIAGNOSIS OF "LOW-GRADE B-CELL LYMPHOMA, BEST CLASSIFIED AS MARGINAL ZONE LYMPHOMA WITH FOLLICULAR COLONIZATION" WAS LOCATED ON A LATER PAGE OF THE MEDITECH ANATOMICAL PATHOLOGY SPECIMEN REPORT WITH THE INTEGRATED (B)(6) CLINIC REPORT. DELAYED PATIENT CARE THIS STATEMENT SUPPORTING THE CANCER DIAGNOSIS WAS "NOT RECOGNIZED" AND THUS "NOT CONVEYED TO THE PATIENT AT THAT TIME". CONSEQUENTLY, THE PATIENT WAS REFERRED TO MEDICAL ONCOLOGY IN (B)(6) 2025 INSTEAD OF (B)(6) 2025. LOGAN HEALTH ATTRIBUTED THE CAUSE OF THE REPORTED ISSUE TO "USER ERROR".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2308343 EXPANSE LABORATORY / GENETICS / MICROBIOLOGY AND ANATOMICAL PATHOLOGY EXPANSE LABORATORY / GENETICS / MICROBIOLOGY AND ANATOMICAL PATHOLOGY JQP MEDICAL INFORMATION TECHNOLOGY, INC. EXPANSE 2.1 00863529000155

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Other