BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFECODES HLA-A ERES SSO TYPING KIT

    MDR report key: 11022134 · Received December 16, 2020

    Report

    Report Number
    2183608-2020-00002
    Event Type
    Malfunction
    Date Received
    December 16, 2020
    Date of Event
    September 19, 2020
    Report Date
    February 3, 2021
    Manufacturer
    IMMUCOR GTI DIAGNOSTICS, INC.
    Product Code
    MZI
    UDI-DI
    10888234400011
    PMA / PMN Number
    BK130075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 0

    THE ROOT CAUSE OF THE MISTYPING WAS A LIMITATION OF THE ASSAY FOR RARE AMBIGUITIES. IMMUCOR GTI DIAGNOTICS INC. MAKES NO CLAIMS THAT OUR TESTS ARE COMPARABLE TO NEXT-GENERATION SEQUENCING (NGS). IN ADDITION THE FOLLOWING DESCRIPTION IS INCLUDED IN THE IFU (LC1436IVDEN REV. K): "RESULTS FROM THESE KITS ARE NOT TO BE USED AS THE SOLE BASIS UPON WHICH A CLINICAL DECISION AFFECTING THE PATIENT IS MADE."

    Description of Event or Problem · 1

    A COMPLAINT ((B)(4)) WAS RECEIVED ON NOVEMBER 17, 2020 FROM A CUSTOMER IN FRANCE DESCRIBING THAT LIFECODES HLA-A ERES SSO TYPING WITH LOT 3008199 AND IMGT 3.39 RESULTED IN TYPING A*03:01, A*68:02. THE LAB ALSO TESTED WITH AN ALTERNATE VENDOR PRODUCT; NGS (OMIXON) WITH A RESULT OF A*03:01,A*68:187. PER LIFECODES HLA-A ERES SSO TYPING RESULTS, THE A*68:187 AS OBTAINED WITH THE NGS METHOD IS NOT PRESENT. SAMPLE ID: (B)(6). LOT #: 3008199. CATALOG #: 628913. CUSTOMER HAS BEEN REQUESTED TO PROVIDE DNA SAMPLE TO ALLOW TESTING TO CONFIRM OR NEGATE THE COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1489328 LIFECODES HLA-A ERES SSO TYPING KIT QUALITATIVE TEST FOR HLA, NON-DIAGNOSTIC MZI IMMUCOR GTI DIAGNOSTICS, INC. 628913 3008199 10888234400011

    Patients

    Seq Age Sex Outcome Treatment
    1