BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFECODES HLA-DQA1/B1 SSO TYPING KIT

    MDR report key: 7542134 · Received May 24, 2018

    Report

    Report Number
    2183608-2018-00010
    Event Type
    Malfunction
    Date Received
    May 24, 2018
    Date of Event
    February 15, 2018
    Report Date
    February 26, 2018
    Manufacturer
    IMMUCOR GTI DIAGNOSTICS, INC.
    Product Code
    MZI
    UDI-DI
    10888234400462
    PMA / PMN Number
    BK150302
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IMMUCOR RECEIVED A CUSTOMER COMPLAINT ON 26 FEBRUARY 2018 ((B)(4)) FROM A CUSTOMER THAT CONTACTED IMMUCOR REGARDING EIGHT SAMPLES ACROSS THREE RUNS THAT GENERATED A MISTYPE WITH LIFECODES HLA-DQA1/B1 SSO TYPING KIT (LOT 3006117). THE CUSTOMER REPORTS THAT FOR THESE SAMPLES THE DQA PROBE 207 WAS FALSE NEGATIVE RESULTING IN DQA SAMPLE MISTYPE FOR DQA1*02. IN ALL CASES, THE SAMPLES WERE TYPED AS DQA1*01 HOMOZYGOUS BY LIFECODES HLA-DQA1/DQB1 SSO TYPING KIT LOT 3006117. THE SAMPLES WERE REPEATED FOR DQA LOCUS BY THE CUSTOMER ON SSP/LINKSEQ AND THE REPEAT TYPING RESULTS WERE DQA1*01, DQA1*02. THE CUSTOMER INFORMED IMMUCOR THAT NO INCORRECT RESULTS WERE REPORTED. THE CUSTOMER CHOSE TO REPEAT THE TYPINGS BY ANOTHER METHOD DUE TO PROBE 207 BEING CLOSE TO THE THRESHOLD AND DUE TO KNOWN GENE ASSOCIATIONS WITH DRB1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384717 LIFECODES HLA-DQA1/B1 SSO TYPING KIT LIFECODES HLA-DQA1/B1 SSO TYPING KIT MZI IMMUCOR GTI DIAGNOSTICS, INC. 3006117 10888234400462

    Patients

    Seq Age Sex Outcome Treatment
    1