BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATCH IT! DNA SOFTWARE

    MDR report key: 11307749 · Received February 10, 2021

    Report

    Report Number
    2183608-2021-00001
    Event Type
    Malfunction
    Date Received
    February 10, 2021
    Date of Event
    January 15, 2021
    Report Date
    April 2, 2021
    Manufacturer
    IMMUCOR GTI DIAGNOSTICS, INC.
    Product Code
    MZI
    UDI-DI
    10888234400394
    PMA / PMN Number
    BK190439
    Removal / Correction Number
    FA-WKS-21-001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    10FEB2021 AB: FIELD ACTION PROCESS UNDERWAY. WILL SEND FOLLOW UP REPORT WHEN FSCA NUMBER IS OBTAINED.

    Description of Event or Problem · 0

    THIS IS A FOLLOW UP TO THE INITIAL REPORT #2183608-2021-00001. EFS CRETEIL (ILE DE FRANCE) REPORTED AN ERROR WITH A LIST OF AMBIGUITIES ON IMGT 3.39V2 AND MATCHIT! DNA SOFTWARE VERSION 1.2.4 WHICH SHOWED A NON-CONFORMITY IN THE RESULT. THE TYPING RESULT GIVEN BY NEXT GENERATION SEQUENCING OMIXON IS A*24:02,A*24:314. THE LIFECODES HLA SSO TYPING RESULT GAVE THE SAME RESULT AS OMIXON IN G GROUP:A*24:02,24:26. FOR INFORMATION A*24:26 AND A*24:314 ARE PART OF SAME G GROUP, A*24:26G, A*24:26 OR A*24:314 HAVE THE SAME PROBE HIT IN ALLELE COMPARISON IN LIFECODES HLA-A STANDARD AND LIFECODES HLA-AERES. WHEN THE LOCUS RESULTS OF LIFECODES HLA-AERES IS MERGED TO THE LOCUS RESULTS OF LIFECODES HLA-A STANDARD, THE LIST OF ALLELES DOES NOT CONTAIN THE ALLELE A*24:314. THE CUSTOMER TRIED TO ANALYZE THE CSV RESULT WITH IMGT 3.41 AND THE SAME ERROR OCCURRED. WHEN RUN WITH LIFECODES HLA-A SSO TYPING KIT THE RESULTS WERE CORRECT, BUT WHEN THE LOCUS RESULTS WERE MERGED A*24:314 WAS NO LONGER PRESENT. UPON INVESTIGATION, IT WAS DISCOVERED THAT ALLELES WERE BEING TRUNCATED ON IMPORT OF EXP FILES. A SQL FUNCTION, UTILFN_SPLIT, INVOLVED IN THE IMPORT IS LIMITING THE NUMBER OF CHARACTERS TO 4000 CHARACTERS. THIS AFFECTS THE ALLELES THAT ARE IMPORTED INTO MATCH IT!, LIMITING THE ALLELES FOR SOME LOCI. THE COMPLAINT HAS RESULTED IN A FIELD ACTION. THE FIELD ACTION NUMBER IS FA-WKS-21-001. WHEN THE CUSTOMER MERGED THE HLA-A ERES AND HLA-A RESULTS IN MATCH IT! DNA SOFTWARE VERSION 1.2, THE PATIENT SAMPLE RESULTS, A*24:02, 24:314 NO LONGER APPEARED IN THE POSSIBLE SAMPLE TYPINGS. THE SAMPLE REPORTED AS A*24:02, 24:26 INSTEAD OF A*24:02, 24:314. A*24:02, 24:314 WAS MISSING FROM THE LIST OF ALLELES. THE MATCH IT! DNA SOFTWARE HAS THE POTENTIAL TO MISTYPE A SAMPLE. THE ERROR DOES NOT CAUSE A CHANGE IN SEROLOGICAL TYPING BUT COULD RESULT IN A MISTYPE IF A SINGLE PAIR OF ALLELES IS REPORTED. THE INVESTIGATION CONCLUDED THIS ERROR, BASED ON THE REACTIVITY PATTERNS AND THE POSSIBLE NUMBER OF ALLELES FOR EACH LOCI, IS ONLY APPLICABLE TO LIFECODES HLA-A TYPING KIT, LIFECODES HLA-A ERES TYPING KIT, LIFECODES HLA-B ERES TYPING KIT AND LIFECODES HLA-CERES TYPING KIT WHEN USING MATCHIT! DNA SOFTWARE V1.2 OR V1.3 FOR ANALYSIS. THE CUSTOMER WILL RECEIVE A NOTIFICATION REGARDING THE FIELD ACTION AND FURTHER STEPS THAT NEED TO BE PERFORMED. CUSTOMER ACTIONS TO BE TAKEN: 1. RETURN CUSTOMER RESPONSE FORM. 2. UNTIL THE SOFTWARE REVISION IS RELEASED, DIRECTIONS ARE PROVIDED IN THE NOTIFICATION ABOUT ASSIGNMENT OF THE ALLELE PAIRS AFFECTED BY THIS ANOMALY. 3. CUSTOMERS CAN ALSO MANUALLY INTERPRET THE DATA USING THE LIFECODES HLA-SSO TYPING KITS PRODUCT INSERT, LC1436IVDEN REVISION K, RESULTS SECTION. THIS IS DESCRIBED IN THE NOTIFICATION LETTER. A SOFTWARE UPDATE WILL BE RELEASED ON OR BEFORE 4/9/2021 WHICH WILL SOLVE THE ISSUE.

    Description of Event or Problem · 0

    (B)(6) REPORTED AN ERROR WITH A LIST OF AMBIGUITIES ON IMGT 3.39V2 AND MATCHIT! DNA SOFTWARE VERSION (B)(4) WHICH SHOWED A NON-CONFORMITY IN THE RESULT. (B)(6). UPON INVESTIGATION, IT WAS DISCOVERED THAT ALLELES WERE BEING TRUNCATED ON IMPORT OF EXP FILES. A SQL FUNCTION, UTILFN_SPLIT, INVOLVED IN THE IMPORT IS LIMITING THE NUMBER OF CHARACTERS TO 4000 CHARACTERS. THIS AFFECTS THE ALLELES THAT ARE IMPORTED INTO MATCH IT!, LIMITING THE ALLELES FOR SOME LOCI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205049 MATCH IT! DNA SOFTWARE MATCH IT! DNA SOFTWARE MZI IMMUCOR GTI DIAGNOSTICS, INC. 888623 10888234400394

    Patients

    Seq Age Sex Outcome Treatment
    1