BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFECODES HLA-B SSO TYPING KIT, LIFECODES HLA-B ERES SSO TYPING KIT

    MDR report key: 7542142 · Received May 24, 2018

    Report

    Report Number
    2183608-2018-00011
    Event Type
    Malfunction
    Date Received
    May 24, 2018
    Date of Event
    February 26, 2018
    Report Date
    March 2, 2018
    Manufacturer
    IMMUCOR GTI DIAGNOSTICS, INC.
    Product Code
    MZI
    UDI-DI
    10888234400028
    PMA / PMN Number
    BK130075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT WAS RECEIVED ON MARCH 2, 2018 ((B)(4)) DESCRIBING THAT WHEN REPORTS WERE GENERATED USING PRODUCT NUMBER 628915, LOT NUMBER 01117A OF LIFECODES HLA-B SSO TYPING KIT THE SEROLOGICAL EQUIVALENT FOR B*27:08 WAS SHOWN TO BE BW4 RATHER THAN THE CORRECT BW6. IMMUCOR GTI DIAGNOSTICS QUALITY CONTROL REVIEWED THE COMPLAINT AND DISCOVERED THAT THE CHANGE WAS DUE TO A TRANSCRIPTION ERROR DURING CREATION OF HLA-B PROBE HIT TABLES FOR 3.29.0 ALLELE DATABASE SEROLOGICAL EQUIVALENCE FILE OF THE DATABASE FILES. THE HLA-B ALLELE B*27:08 SEROLOGICAL EQUIVALENCE CHANGED FROM A B27 (BW6) IN ALLELE DATABASE 3.27.0 TO B2708 (BW4) IN ALLELE DATABASE 3.29.0. THE HLA-B ALLELE B*27:08 SEROLOGICAL EQUIVALENCE WAS INCORRECTLY ASSIGNED BW4. AN NCR (NCR 1762) WAS OPENED TO ADDRESS THE ISSUE. RESOLUTION OF THIS ERROR WAS MADE WITH A CORRECTION TO THE DATABASE, A CUSTOMER NOTIFICATION (CORRECTION) AND A TECHNICAL UPDATE LOADED TO THE IMMUCOR WEBSITE FOR THE AFFECTED LOTS OF PRODUCT. THE SEROLOGICAL EQUIVALENT (BW4 OR BW6) IS ASSIGNED BY THE WORLD HEALTH ORGANIZATION (WHO). LIFECODES HLA SSO-B TYPING KIT OR LIFECODES HLA SSO-BERES AFFECTED KITS: PRODUCT NAME: LIFECODES HLA-B SSO TYPING KIT, LOT#/SERIAL #: 01117A, LIST # PART#: 628915, EXPIRATION DATE: 2018-11-30; LIFECODES HLA-B SSO TYPING KIT, 06036A, 628915, 2018-05-31; LIFECODES HLA-BERES SSO TYPING KIT, 01117B, 628917, 2018-12-31; LIFECODES HLA-BERES SSO TYPING KIT, 06036B, 628917, 2018-12-31. THE LIFECODES HLA SSO-B AND HLA SSO-B ERES TYPING KITS ARE MEETING PERFORMANCE CLAIMS. THIS ISSUE IS A DOCUMENTATION ERROR NOT ASSOCIATED WITH A PERFORMANCE CLAIM OR WHO STANDARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384899 LIFECODES HLA-B SSO TYPING KIT, LIFECODES HLA-B ERES SSO TYPING KIT QUALITATIVE TEST FOR HLA, NON-DIAGNOSTIC MZI IMMUCOR GTI DIAGNOSTICS, INC. 01117A 10888234400028

    Patients

    Seq Age Sex Outcome Treatment
    1