BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFECODES HLA-B SSO TYPING KIT

    MDR report key: 10868731 · Received November 19, 2020

    Report

    Report Number
    2183608-2020-00001
    Event Type
    Malfunction
    Date Received
    November 19, 2020
    Date of Event
    October 5, 2020
    Report Date
    October 21, 2020
    Manufacturer
    IMMUCOR GTI DIAGNOSTICS, INC.
    Product Code
    MZI
    UDI-DI
    10888234400028
    PMA / PMN Number
    BK130075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED A MISTYPED SAMPLE FOR LIFECODES HLA-B SSO TYPING KIT LOT 3008083, SAMPLE ID (B)(4), TESTED ON (B)(6) 2020. THE RESULTS ON THE FIRST RUN WERE (B)(6) . THERE WERE MANY FAILED SAMPLES (7 OUT OF 10) DURING THIS RUN WHICH LED THE USER TO RE-READ THE ASSAYS. ADDITIONALLY THE SAMPLE IN QUESTION HAD FAILED AMPLIFICATION FOR HLA-A AND HLA-C LOCI. THE CUSTOMER DID NOT RUN A POSITIVE CONTROL WITH THE ASSAY. A NEW SAMPLE WAS OBTAINED AND TESTED ALONG WITH THE ORIGINAL SAMPLE ON (B)(6) 2020. THE TYPING WAS (B)(6) FOR BOTH THE ORIGINAL AND NEW SAMPLE. THIS RESULT, FOR THE REPEAT TESTING OF THE ORIGINAL SAMPLE AND A NEW SAMPLE HAS BEEN CORRECTED TO THE ORIGINAL REPORT. PRIOR TO THE SECOND TESTING EVENTS, THE CUSTOMER PERFORMED MAINTENANCE ON THE LUMINEX INSTRUMENT. DUE TO THE ORIGINAL TESTING EVENT ENCOUNTERING 7 OF 10 SAMPLES AS HAVING FAILED AMP (NOT INCLUDING THE SAMPLE IN QUESTION), THIS MAY BE INDICATIVE TO TECHNICAL ERROR DURING TESTING. THE NATURE OF THE ERROR CANNOT BE DETERMINED FROM THE RAW DATA. THE CUSTOMER HAS BEEN INFORMED TO RUN A POSITIVE CONTROL AND WHEN REVIEWING SAMPLES TO CHECK FOR COMMON HAPLOTYPES. WITHIN THE IFU, IT IS RECOMMENDED TO INCLUDE ONE NEGATIVE AND POSITIVE CONTROL. VALUES ARE INCLUDED IN THE IFU FOR CONSENSUS PROBES TO EXCEED VALUES SET FORTH IN PRODUCT LABELING. THERE IS NO HARM KNOWN OR EXPECTED TO THE PATIENT DUE TO THE FIRST RESULT REPORTING. COMPLAINT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1337932 LIFECODES HLA-B SSO TYPING KIT TEST, QUALITATIVE, FOR HLA, NON-DIAGNOSTIC MZI IMMUCOR GTI DIAGNOSTICS, INC. 628915 3008083 10888234400028

    Patients

    Seq Age Sex Outcome Treatment
    1