BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEICA ASP300

    MDR report key: 2062727 · Received April 14, 2011

    Report

    Report Number
    8010478-2011-00003
    Event Type
    Injury
    Date Received
    April 14, 2011
    Date of Event
    March 13, 2011
    Report Date
    March 16, 2011
    Manufacturer
    LEICA BIOSYSTEMS GMBH
    Product Code
    IEO
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS A RESULT OF THE DAMAGED TISSUES, THE CUSTOMER COULD NOT EVALUATE THEM AND PATIENTS REQUIRED REBIOPSY. THE UNIT WAS EVALUATED BY A LEICA SERVICE SUPPORT PRODUCT SPECIALIST. THE ANALYSIS OF THE RUN LOGS INDICATED THAT THE CAUSE FOR THE DAMAGED TISSUE WAS DUE TO INSUFFICIENT REAGENTS IN THE BOTTLES. AS A RESULT, THE PROCESSING STOPPED BECAUSE, IT COULD NOT CONTINUE WITHOUT THE SUFFICIENT AMOUNT OF REAGENTS IN THE BOTTLES. THE INSTRUMENT SELECTED THE ALTERNATIVE STATION OF REAGENTS AS WELL BUT WITHOUT SUCCESS. BECAUSE, THE CUSTOMER DID NOT RESPOND TO THE UNIT'S ALARM, THE TISSUE REMAINED IN THE ALCOHOL AND DAMAGED THE TISSUES. AFTER THE REAGENT BOTTLES WERE REFILLED, THE CUSTOMER CONDUCTED A NEW PROCESSING RUN WHICH CONFIRMED THE PROPER FUNCTIONING OF THE UNIT. THE CUSTOMER WAS INSTRUCTED TO FOLLOW THE MAINTENANCE INSTRUCTIONS IN THE USER MANUAL WHICH REQUIRES THE CORRECT STATE OF THE REAGENT BOTTLES.

    Description of Event or Problem · 1

    THE INSTRUMENT STOPPED DURING PROCESSING. CONSEQUENTLY, THE TISSUE WAS DAMAGED BECAUSE, IT REMAINED IN ALCOHOL FOR SEVERAL HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEICA ASP300 TISSUE PROCESSOR IEO LEICA BIOSYSTEMS GMBH ASP300

    Patients

    Seq Age Sex Outcome Treatment
    1 Other