BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID CORE XT

    MDR report key: 19497700 · Received June 10, 2024

    Report

    Report Number
    3006413195-2024-00010
    Event Type
    Malfunction
    Date Received
    June 10, 2024
    Date of Event
    April 15, 2024
    Report Date
    June 10, 2024
    Manufacturer
    PROGENIKA BIOPHARMA, S.A
    Product Code
    PEP
    UDI-DI
    08437013457019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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 OF GYPA EXONS 1 TO 7. THE VARIANT C.38-66A>G IN HETEROZYGOUS WAS DETECTED ON EXON 2 OF THE GENE GYPA, AFFECTING THE BINDING REGION OF ID CORE XT EXON 2 FORWARD PRIMER. THE ID CORE XT PREDICTED GENOTYPE FOR THIS SAMPLE WAS GYPA*N HOMOZYGOUS WITH AN ASSOCIATED PREDICTED PHENOTYPE M-N+, BUT THE DNA SEQUENCING DETECTS THE GENOTYPE GYPA*M(C.38-66G), GYPA*N WITH A PREDICTED PHENOTYPE M+N+, CONSISTENT WITH SEROLOGY RESULT M+. THIS RARE VARIANT IS NOT DESCRIBED IN THE LITERATURE AND AFFECTS TO THE DETECTION OF THE GYPA*M ALLELE BY ID CORE XT. ID CORE XT PREDICTED GENOTYPE RESULT FOR THIS SAMPLE WAS GYPA*N, BUT ACCORDING TO THE SEQUENCING RESULT AND THE M POSITIVE SEROLOGY DATA, THE PREDICTED PHENOTYPE IS M POSITIVE. THIS FALSE NEGATIVE RESULT OBTAINED BY ID CORE XT IS CONSIDERED A DISCREPANT RESULT AND THEN A MALFUNCTION. THIS CASE REPORT IS ASSOCIATED WITH A SPECIFIC LIMITATION OF ID CORE XT ASSAY DESCRIBED IN THE ID CORE XT PACKAGE INSERT (LIMITATION 9.4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SAMPLE (B)(6) FROM "LIFESOUTH COMMUNITY BLOOD CENTER", WAS TESTED WITH SEROLOGY. THE TEST RESULT WAS POSITIVE (M+), WHICH CONTRASTED WITH TWO MOLECULAR TYPING PERFORMED ON (B)(6) 2024 AND (B)(6) 2024, USING THE ID CORE XT ASSAY WHICH PROVIDED NEGATIVE RESULTS (M-) WITH ID CORE XT ANALYSIS SOFTWARE V3.0.5.12.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666186 ID CORE XT ANTIGEN GENOTYPING TEST PEP PROGENIKA BIOPHARMA, S.A 0203000032 08437013457019

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown