BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID CORE XT

    MDR report key: 18413957 · Received December 28, 2023

    Report

    Report Number
    3006413195-2023-00022
    Event Type
    Malfunction
    Date Received
    December 28, 2023
    Date of Event
    November 30, 2023
    Report Date
    December 28, 2023
    Manufacturer
    PROGENIKA BIOPHARMA, S.A
    Product Code
    PEP
    UDI-DI
    08437013457019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE GENOMIC DNA SAMPLE WAS SENT TO GRIFOLS LABORATORY SOLUTIONS FOR DNA SEQUENCING (NGS). THE NGS SEQUENCING INTERROGATED KEL PROMOTER AND EXONS 1-19, IDENTIFYING THE VARIANT KEL* C.2107 G>C IN HETEROZYGOSIS. THE INFERRED GENOTYPE OF SEQUENCING IS KEL*01M.06(1680A), KEL*K (KEL*02) AS DESCRIBED BY ISBT, AND ITS PREDICTED KMOD PHENOTYPE WOULD BE ASSOCIATED WITH NO EXPRESSION OF KELL ANTIGENS.ID CORE XT REPORTED A PREDICTED K+ PHENOTYPE, BUT KEL* C.2107 G>C VARIANT, NOT INTERROGATED BY ID CORE XT, IS ASSOCIATED WITH K- PHENOTYPE. THE FALSE POSITIVE RESULT OBTAINED BY ID CORE XT IS CONSIDERED A DISCREPANT RESULT AND THEN A MALFUNCTION. THIS CASE REPORT IS ASSOCIATED WITH LIMITATIONS OF ID CORE XT ASSAY, AS DESCRIBED IN THE ID CORE XT PACKAGE INSERT (SEC 1 AND 10 ASSAY LIMITATIONS).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SAMPLE W051523064512, FROM MEMORIAL BLOOD CENTER, WAS TESTED WITH SEROLOGY PROVIDING A NEGATIVE RESULT (K-), WHICH CONTRASTED WITH THE MOLECULAR TYPING PERFORMED ON 30NOV23 USING THE ID CORE XT ASSAY WHICH PROVIDED POSITIVE RESULTS (K+) WITH ID CORE XT ANALYSIS SOFTWARE V3.0.4.1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1401919 ID CORE XT ANTIGEN GENOTYPING TEST PEP PROGENIKA BIOPHARMA, S.A 0203000030 08437013457019

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown