BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DONORSCREEN-HLA CLASS I AND CLASS II

    MDR report key: 7542214 · Received May 24, 2018

    Report

    Report Number
    2183608-2018-00012
    Event Type
    Malfunction
    Date Received
    May 24, 2018
    Date of Event
    March 31, 2018
    Report Date
    April 9, 2018
    Manufacturer
    IMMUCOR GTI DIAGNOSTICS, INC.
    Product Code
    MZI
    UDI-DI
    10888234500193
    PMA / PMN Number
    BK070045
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE DONORSCREEN-HLA CLASS I AND CLASS II ASSAY IS USED BY A LABORATORY GROUP, (B)(4) WHICH HAS SEVERAL SITES IN THE UNITED STATES. CTS REPORTED AN HLA CLASS II RESULT DISCREPANCY BETWEEN TESTING PERFORMED AT 2 SITES, (B)(4). THE SAMPLE WAS A FRESH SAMPLE, NEVER FROZEN, DRAWN ON (B)(6) 2018 IN 2 SEPERATE TUBES WHICH WAS REFRIGERATED UNTIL (B)(6) 2018 FOR TESTING. TESTING WAS PERFORMED ON (B)(6) 2018. THE TESTING WAS PERFORMED AT BOTH SITES ABOUT AN HOUR APART. DISCREPANCY IN RESULTS FOR TWO SAMPLES BETWEEN THE SITES WAS REPORTED. THERE IS CONFLICT IN THE INFORMATION FROM THE CUSTOMER WHERE THE CUSTOMER STATED ONE SAMPLE WAS AFFECTED BUT DATA AND SOME DESCRIPTION PROVIDED BY CUSTOMER IS THAT TWO SAMPLES WERE AFFECTED. THE HLA CLASS I RESULTS WERE NEGATIVE FOR THE SAMPLES AT BOTH SITES. SITE: QUICKSTEP SERIAL #: SAMPLE ID: RESULT: RESULT REPORTED KIT LOT #: 1, (B)(4) , (B)(4) - ( NEG), NO, 3006245A/B. 2, (B)(4), (B)(4) + (POS), YES, SAME. 1, (B)(4), (B)(4) - ( NEG), NO, SAME. 2, (B)(4), (B)(4) + (POS), YES, SAME. THE CUSTOMER STATED THAT THEIR QA DEPARTMENT DETERMINED THE POS (POSITIVE) RESULT WOULD BE REPORTED FOR THIS SAMPLE. FOUR CONTACTS WITH THE CUSTOMER WHO PLACED THE COMPLAINT WERE ATTEMPTED. AS OF THIS REPORT, RESPONSE HAS STILL NOT BEEN RECEIVED FROM THE CONTACT AT THE CUSTOMER SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382884 DONORSCREEN-HLA CLASS I AND CLASS II TEST, HLA PRODUCT CODE: MZI MZI IMMUCOR GTI DIAGNOSTICS, INC. 3006245A/B 10888234500193

    Patients

    Seq Age Sex Outcome Treatment
    1