BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASP6025

    MDR report key: 23232042 · Received October 7, 2025

    Report

    Report Number
    8010478-2025-00029
    Event Type
    Injury
    Date Received
    October 7, 2025
    Date of Event
    September 8, 2025
    Report Date
    December 2, 2025
    Manufacturer
    LEICA BIOSYSTEMS NUSSLOCH GMBH
    Product Code
    IEO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATING ENGINEER, QUALITY ASSURANCE & REGULATORY AFFAIRS HAS DETERMINED THE FOLLOWING: ACCORDING TO THE DEVICE LOGS STEP AN EXTERNAL POWER OUTAGE OCCURRED AT 13:51 DURING THE 9TH PROCESSING STEP. THE POWER OUTAGE LASTED FOR 15 MINUTES. AN ANALYSIS OF THE DEVICE LOGS SHOWED THAT THE POWER OUTAGE DID NOT AFFECT ANY PROCESSES THAT COULD HAVE CAUSED THE WHITE APPEARANCE OF THE SAMPLES DESCRIBED BY THE CUSTOMER. THE INSTRUMENT DETERMINED THAT THE ENVIRONMENT OF STEP 9 WAS EQUIVALENT TO THE SAFE REAGENT ENVIRONMENT, SO IT MAINTAINED THE CURRENT STATE. THE CUSTOMER DETECTED THE POWER OUTAGE OF THE INSTRUMENT, ADJUSTED THE DURATION OF THE 9TH STEP (FROM 6 HOURS TO 5 HOURS) AND SUBSEQUENT STEPS AT 14:10, AND THEN RESTARTED THE PROTOCOL FROM THE 9TH STEP. ACCORDING TO THE CUSTOMER, AT THE START OF THE RUN, THEY MANUALLY REFILLED A XYLENE REAGENT BOTTLE THAT WAS LOW, AND THERE IS A POSSIBILITY THAT THE WRONG REAGENT MAY HAVE BEEN ADDED AT THAT TIME. GIVEN BOTH THE LOG FILE ANALYSIS, AS WELL AS THE STATEMENT FROM THE CUSTOMER, THE FINAL ROOT CAUSE FOR THIS CASE HAS BEEN CONCLUDED TO BE AN APPLICATION ISSUE WITH AN INCORRECTLY CHANGED REAGENT. LEICA BIOSYSTEMS HAS BEEN INFORMED THAT AFTER CLEANING AND RE-FILLING OF THE XYLENE REAGENT BOTTLE WITH FRESH XYLENE THE PROCESSING QUALITY HAS RETURNED TO NORMAL. THE DEVICE IS PERFORMING AS EXPECTED.

    Description of Event or Problem · 0

    ON SEPTEMBER 8TH, 2025 LEICA BIOSYSTEMS RECEIVED A COMPLAINT THAT, FOLLOWING A SCHEDULED POWER OUTAGE AT THE CUSTOMER SITE ON (B)(6) 2025, THE SAMPLE PROCESSING OF THE IMPACTED RUN WAS NEGATIVELY IMPACTED. ON (B)(6) 2025, LEICA BIOSYSTEMS NUSSLOCH GMBH WAS INFORMED THAT ONE TISSUE SAMPLE OF THE IMPACTED RUN COULD NOT BE DIAGNOSED. ON (B)(6) 2025, LEICA BIOSYSTEMS NUSSLOCH GMBH WAS INFORMED THAT ONE PATIENT HAD TO BE RE-BIOPSIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2614527 ASP6025 PROCESSOR, TISSUE, AUTOMATED IEO LEICA BIOSYSTEMS NUSSLOCH GMBH ASP6025 120V/50-60 HZ

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown