BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEICA ASP300

    MDR report key: 14318006 · Received May 7, 2022

    Report

    Report Number
    1423337-2022-00054
    Event Type
    Injury
    Date Received
    May 7, 2022
    Date of Event
    April 8, 2022
    Report Date
    May 20, 2022
    Manufacturer
    LEICA BIOSYSTEMS NUSSLOCH GMBH
    Product Code
    IEO
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    LEICA BIOSYSTEMS RECEIVED A COMPLAINT OF HARD AND BRITTLE BIOPSY TISSUES FROM SUBOPTIMAL TISSUE PROCESSING ON THE ASP300, TISSUE PROCESSOR. ON (B)(6) 2022, THE COMPLAINANT REPORTED TO LEICA BIOSYSTEMS THAT BIOPSY TISSUE ONLY WAS NOT DIAGNOSABLE. A LEICA BIOSYSTEMS FIELD APPLICATIONS SPECIALIST FOLLOWED UP WITH THE CUSTOMER AND THE ONLY ADDITIONAL INFORMATION PROVIDED WAS THAT NO RE-BIOPSIES WERE PERFORMED. THREE (3) ATTEMPTS BY AT LEAST TWO (2) DIFFERENT METHODS TO OBTAIN THE PATIENT IDENTIFIER INFORMATION WERE COMPLETED; HOWEVER, THE CUSTOMER HAS NOT PROVIDED LEICA BIOSYSTEMS THIS INFORMATION.

    Description of Event or Problem · 0

    ON 11 MAY 2022, THE COMPLAINANT CONFIRMED IT WAS TWO (2) CASES WHICH WERE NOT DIAGNOSABLE, A CORE BIOPSY AND A GI BIOPSY. THE COMPLAINANT IS NOT PROVIDING ANY PATIENT IDENTIFIER INFORMATION FOR THE TWO (2) CASES INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1068104 LEICA ASP300 ASP300 IEO LEICA BIOSYSTEMS NUSSLOCH GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other