BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOGOS

    MDR report key: 8938652 · Received August 28, 2019

    Report

    Report Number
    1000391282-2019-00001
    Event Type
    Malfunction
    Date Received
    August 28, 2019
    Date of Event
    August 1, 2019
    Report Date
    February 7, 2020
    Manufacturer
    MILESTONE S.R.L.
    Product Code
    IEO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE RECEIVED, TESTED, EXECUTED SOME DUMMY PROCESSES, WITHOUT SPECIMENS, BUT NOT FAULTY FOUND: TEMPERATURE, DOWNLOAD AND UPLOAD OF REAGENTS FROM TANK TO PROCESS-CAVITY PERFORMED CORRECTLY WITHOUT ANY ERROR MESSAGES SHOWN. AS INDICATED IN B5, ONLY REAGENTS CAN EXPLAIN THE EVENT, THOSE CAN BE IDENTIFIED AS INADEQUATE FOR SEQUENCE OR DEGREE OF PURITY (MAYBE TOO EHAUST, NOT CHANGED IN TIME). WE CONSIDER THIS EVENT CLOSED.

    Description of Event or Problem · 0

    DIFFICULT DIAGNOSIS OF TISSUE/SPECIMEN PREPARED BY THE TISSUE PROCESSOR. DIAGNOSIS ANYWAY WERE POSSIBLE FOR ALL CASSETTES PROCESSED. REAGENT INADEQUATE FOR THE PROCESS SELECTED.

    Additional Manufacturer Narrative · 1

    DEVICE NOT YET EVALUTAED AS IT IS TRAVELLING IN THESE DAYS.

    Description of Event or Problem · 1

    DIFFICULT DIAGNOSIS OF TISSUE/SPECIMEN PREPARED BY THE TISSUE PROCESSOR. DIAGNOSIS ANYWAY WERE POSSIBLE FOR ALL CASSETTES PROCESSED. SUSPECT MIXING OF REAGENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    735315 LOGOS AUTOMATED TISSUE PROCESSOR IEO MILESTONE S.R.L. 61502/140

    Patients

    Seq Age Sex Outcome Treatment
    1 PROCESSING REAGENTS USED AT LABORATORY SITE| PROCESSING REAGENTS USED AT LABORATORY SITE