BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASP6025

    MDR report key: 11778666 · Received May 5, 2021

    Report

    Report Number
    8010478-2021-00004
    Event Type
    Injury
    Date Received
    May 5, 2021
    Date of Event
    April 6, 2021
    Report Date
    October 30, 2023
    Manufacturer
    LEICA BIOSYSTEMS NUSSLOCH GMBH
    Product Code
    IEO
    UDI-DI
    04049188158819
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE INSTRUMENT LOGS WERE EVALUATED BY A SERVICE SUPPORT MANAGER. THE INVESTIGATION REVEALED THE FOLLOWING: NO ERROR DETECTED DURING THE PROCESSING STEPS, THERE WAS AN ABNORMALITY, BUT ONLY IN THE CLEANING STEP WITHOUT TISSUE INVOLVED. PRESUMABLY, THE CAUSE FOR THE SUBOPTIMAL PROCESSED TISSUE WAS DUE TO AN APPLICATION ISSUE. THE CUSTOMER INTERRUPTED THE CYCLE SEVERAL TIME BEFORE THE END, AND THIS COULD HAVE BEEN THE ROOT CAUSE OF THE ISSUE. DUE TO ISSUES USING THE CONCENTRATION MODE, THE CUSTOMER SWITCHED TO THE INSTRUMENT REAGENT MANAGEMENT SYSTEM (RMS) MODE. ADDITIONALLY THE ASP6025 MAIN PCBA WAS REPLACED. THE CUSTOMER CONFIRMED THAT THE DEVICE IS WORKING CORRECTLY SINCE THE CHANGE TO THE INSTRUMENT RMS MODE.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION OF THE INCIDENT IS CURRENTLY UNDERWAY AND A FOLLOW UP WILL BE SUBMITTED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE FOLLOWING THE INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2021 LEICA BIOSYSTEMS RECEIVED A COMPLAINT THAT THE CUSTOMER EXPERIENCED DAMAGED TISSUE SAMPLES DURING PROCESSING ON THEIR ASP6025. AS A RESULT 2 TISSUE SAMPLES HAVE NOT BEEN DIAGNOSED; 1 TISSUE SAMPLE BELONGING TO A FEMALE PATIENT AND 1 TISSUE SAMPLE BELONGING TO A MALE PATIENT. THE 1 FEMALE PATIENT HAS TO BE REBIOPSIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674563 ASP6025 ASP6025 IEO LEICA BIOSYSTEMS NUSSLOCH GMBH 04049188158819

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other