BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PELORIS RAPID TISSUE PROCESSOR

    MDR report key: 3820548 · Received April 11, 2014

    Report

    Report Number
    8020030-2014-00011
    Event Type
    Malfunction
    Date Received
    April 11, 2014
    Date of Event
    March 14, 2014
    Report Date
    March 14, 2014
    Manufacturer
    LEICA BIOSYSTEMS MELBOURNE PTY. LTD.
    Product Code
    IEO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    LEICA BIOSYSTEM RECEIVED A COMPLAINT REGARDING SUB-OPTIMAL PROCESSING OF TISSUE IN APPROXIMATELY 350 CASSETTES FROM TWO (2) PROCESSING RUNS; AND REQUESTED ADVICE/ASSISTANCE FOR RE-PROCESSING THE AFFECTED SAMPLES. ON (B)(6) 2014, LEICA BIOSYSTEMS RECEIVED INFORMATION THAT ALL TISSUE SAMPLES EXHIBITING SUB-OPTIMAL PROCESSING WERE DIAGNOSABLE. INVESTIGATION OF THIS COMPLAINT BY LEICA BIOSYSTEMS IS IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220647 PELORIS RAPID TISSUE PROCESSOR AUTOMATED TISSUE PROCESSOR IEO LEICA BIOSYSTEMS MELBOURNE PTY. LTD. PERLORIS

    Patients

    Seq Age Sex Outcome Treatment
    1