BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HISTOCORE PEARL

    MDR report key: 23036131 · Received September 12, 2025

    Report

    Report Number
    8010478-2025-00027
    Event Type
    Malfunction
    Date Received
    September 12, 2025
    Date of Event
    August 4, 2025
    Report Date
    October 24, 2025
    Manufacturer
    LEICA BIOSYSTEMS NUSSLOCH GMBH
    Product Code
    IEO
    UDI-DI
    04049188198907
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON SEPTEMBER 25, 2025, THE INVESTIGATING LEICA BIOSYSTEMS ENGINEER, QUALITY ASSURANCE & REGULATORY AFFAIRS REPORTED THE FOLLOWING: APPLICATION ISSUE ¿ WRONG REAGENT CHANGED NO ERROR THAT WOULD AFFECT THE PROCESSING PROTOCOL WAS FOUND IN THE LOG. AFTER MEASURING THE ETHANOL CONCENTRATION IN EACH REAGENT BOTTLE, SOME DEVIATIONS IN THE ETHANOL PERCENTAGES WERE OBSERVED. SINCE ALL REAGENTS HAVE BEEN REPLACED WITH FRESH ONES, ALL TEST RESULTS ARE ACCEPTABLE. IT IS SUSPECTED THAT THE CUSTOMER MAY HAVE ACCIDENTALLY FILLED IN THE WRONG ETHANOL WHICH LED TO THE POOR TISSUE PROCESSING QUALITY. AN ANALYSIS OF THE DEVICE LOGS SHOWED THAT THERE WERE NO ERROR CODES RECORDED ASSOCIATED WITH THE EVENT THAT WOULD HAVE AFFECTED THE PROCESSING PROTOCOL. AN EXAMINATION OF THE DEVICE AT THE CUSTOMER SITE BY THE LEICA BIOSYSTEMS APPLICATION CONSULTANT TEAM LEAD REVEALED THAT THERE WERE DEVIATIONS WITH THE ETHANOL GRADIENT CONCENTRATION PERCENTAGES. AN INCORRECT ETHANOL GRADIENT CAN HAVE A NEGATIVE IMPACT ON THE PROCESSING QUALITY OF TISSUE SAMPLES. THE CUSTOMER WAS ADVISED TO REPLACE ALL REAGENTS WITH FRESH STOCK. FOLLOWING THE REPLACEMENT A TEST RUN WAS PERFORMED, AND THE TEST SAMPLES WERE PROCESSED WITH THE EXPECTED QUALITY. FOLLOWING THE RUN FILLING LEVELS AND ETHANOL CONCENTRATIONS WERE DETERMINED TO BE WITHIN SPECIFICATIONS. THE CUSTOMER HAS PURCHASED A HYDROMETER AND HAS CREATED A PLAN TO DOCUMENT ALL FUTURE REAGENT CHANGES. ON (B)(6) 2025, LEICA BIOSYSTEMS WAS INFORMED BY THE CUSTOMER THAT FOLLOWING THE IMPLEMENTATION OF THE ABOVE-MENTIONED PROCESS CHANGES THE DEVICE IS PERFORMING AS EXPECTED.

    Description of Event or Problem · 0

    ON (B)(6) 2025 LEICA BIOSYSTEMS RECEIVED A COMPLAINT THAT ONE OF OUR CUSTOMERS EXPERIENCED SUBOPTIMAL TISSUE PROCESSING IN ONE RUN ON THEIR HISTOCORE PEARL TISSUE PROCESSOR ON (B)(6) 2025. THROUGH FURTHER COMMUNICATION WITH THE CUSTOMER IT WAS DETERMINED THAT ALSO SAMPLES PROCESSED IN ONE RUN ON (B)(6) 2025, AND SEVERAL SAMPLES PROCESSED BETWEEN (B)(6) 2025 SHOWED SUBOPTIMAL TISSUE PROCESSING. IT WAS FURTHER DETERMINED THAT THE CUSTOMER ONLY USES THE HISTOCORE PEARL FOR THE PROCESSING OF HUMAN NON-CLINICAL TISSUES SAMPLES FOR RESEARCH PURPOSES. THEREFORE NO PATIENTS WERE NEGATIVELY IMPACTED BY THIS EVENT.

    Description of Event or Problem · 0

    ON AUGUST 06 2025, LEICA BIOSYSTEMS RECEIVED A COMPLAINT THAT ONE OF OUR CUSTOMERS EXPERIENCED SUBOPTIMAL TISSUE PROCESSING IN ONE RUN ON THEIR HISTOCORE PEARL TISSUE PROCESSOR ON (B)(6)2025. THROUGH FURTHER COMMUNICATION WITH THE CUSTOMER IT WAS DETERMINED THAT ALSO SAMPLES PROCESSED IN ONE RUN ON (B)(6)2025, AND SEVERAL SAMPLES PROCESSED BETWEEN (B)(6)2025 SHOWED SUBOPTIMAL TISSUE PROCESSING. IT WAS FURTHER DETERMINED THAT THE CUSTOMER ONLY USES THE HISTOCORE PEARL FOR THE PROCESSING OF HUMAN NON-CLINICAL TISSUES SAMPLES FOR RESEARCH PURPOSES. THEREFORE, NO PATIENTS WERE NEGATIVELY IMPACTED BY THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2233406 HISTOCORE PEARL PROCESSOR, TISSUE, AUTOMATED IEO LEICA BIOSYSTEMS NUSSLOCH GMBH HISTOCORE PEARL 04049188198907

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other