BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TISSUE-TEK XPRESS(R) X50

    MDR report key: 8086313 · Received November 19, 2018

    Report

    Report Number
    2083544-2018-00007
    Event Type
    Injury
    Date Received
    November 19, 2018
    Date of Event
    October 19, 2018
    Report Date
    November 16, 2018
    Manufacturer
    SAKURA FINETEK USA, INC.
    Product Code
    IEO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USE OF DEGRADED REAGENT IS A SUSPECTED CAUSE; THE INFILTRATION OF FLUID INTO THE TISSUE SAMPLES WAS NOT OPTIMAL. USER STATED THAT THE REAGENT REPLACEMENT SCHEDULE WAS SET AT 300 CASSETTES, AND HE TYPICALLY CHECKS THE TISSUES SPECIMEN VISUALLY AFTER 200 CASSETTES, REPLACES REAGENTS EVERY 200-250 CASSETTES. THE COUNTER INDICATED THAT JUST OVER 200 CASSETTES HAD BEEN PROCESSED WHEN THE AFFECTED RUN WAS FINISHED. AFTER THE INCIDENT, USER PROCESSED SEVEN (7) MORE BIOPSY SAMPLES USING THE SUBJECT INSTRUMENT, FOUND NO ISSUE. THIS IS MOST LIKELY DUE TO A SMALLER VOLUME OF 7 SAMPLES PROCESSED IN THE RETORT COMPARED TO 32 SAMPLES, PRODUCED MORE EFFECTIVE FLUID CIRCULATION AND BETTER QUALITY OUTCOME. USER USED THE TISSUE-TEK XPRESS (R) PROCESSING REAGENT, FORMULA 1, PRODUCT CODE 7731, LOT# 6925-03. THERE IS NO OTHER COMPLAINT RECEIVED FROM OTHER SITES FOR THIS REAGENT LOT. USER STATED THAT HE CONTINUES TO USE THE INSTRUMENT; HOWEVER, CHANGED THE REAGENT REPLACEMENT COUNTER SETTING TO 200 CASSETTES.

    Description of Event or Problem · 1

    SAKURA FINETEK (B)(6) RECEIVED A COMPLAINT ON OCTOBER 20TH, 2018, FROM USER FACILITY IN (B)(6) THAT THIRTY TWO (32) BIOPSY SAMPLES WERE FOUND DRY AND HARD AFTER A RUN WITH THE TISSUE-TEK XPRESS X50 TISSUE PROCESSING INSTRUMENT, SERIAL NUMBER (B)(4). USER WAS ABLE TO SECTION ALL 32 SAMPLES; HOWEVER, FOUND HEMATOXYLIN WAS POORLY STAINED. THIRTY (30) OUT OF 32 SAMPLES WERE DIAGNOSABLE, 4 OUT OF WHICH WERE VERY DIFFICULT TO DIAGNOSE. TWO (2) SAMPLES GAVE A NEGATIVE RESULT WHERE POSITIVE RESULT WAS PREDICTED; THUS, RESULTED IN RE-BIOPSY OF TWO (2) PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    924536 TISSUE-TEK XPRESS(R) X50 X50 IEO SAKURA FINETEK USA, INC. 7750

    Patients

    Seq Age Sex Outcome Treatment
    1 Other