BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID CORE XT

    MDR report key: 17893663 · Received October 9, 2023

    Report

    Report Number
    3006413195-2023-00020
    Event Type
    Malfunction
    Date Received
    October 9, 2023
    Date of Event
    July 18, 2023
    Report Date
    October 9, 2023
    Manufacturer
    PROGENIKA BIOPHARMA, S.A
    Product Code
    PEP
    UDI-DI
    08437013457064
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE GENOMIC DNA SAMPLE WAS SENT TO GRIFOLS LABORATORY SOLUTION FOR DNA SEQUENCING. DNA SEQUENCING INTERROGATED SPECIFIC SEQUENCES: KEL GENE EXONS 1-9. THE KEL GENOTYPE DETECTED TWO KEL*K ALLELES IN AGREEMENT WITH ID CORE XT BUT ALSO A HOMOZYGOUS MUTATION C.1546C>T REPORTED AS KO ALLELE KEL*02N.17. THIS MUTATION IS ASSOCIATED WITH A NULL KO PHENOTYPE WHICH EXPLAINS THE SEROLOGY DISCREPANCY. ID CORE XT REPORTED A PREDICTED K+ PHENOTYPE, BUT KEL*02N.17 ALLELE IS ASSOCIATED WITH A PREDICTED K- PHENOTYPE. THIS 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 8074933, FROM MADRID BLOOD TRANSFUSION CENTER, WAS TESTED WITH SEROLOGY. THE TEST RESULT WAS NEGATIVE (K-), WHICH CONTRASTED WITH THE MOLECULAR TYPING PERFORMED ON (B)(6) 2023, USING THE ID CORE XT ASSAY WHICH PROVIDED POSITIVE RESULTS (K+) WITH ID CORE XT ANALYSIS SOFTWARE V3.0.2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1121226 ID CORE XT ANTIGEN GENOTYPING TEST PEP PROGENIKA BIOPHARMA, S.A 0203000029 08437013457064

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown