BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID CORE XT

    MDR report key: 12516397 · Received September 22, 2021

    Report

    Report Number
    3006413195-2021-00007
    Event Type
    Malfunction
    Date Received
    September 22, 2021
    Date of Event
    August 12, 2021
    Report Date
    September 22, 2021
    Manufacturer
    PROGENIKA BIOPHARMA, S.A
    Product Code
    PEP
    UDI-DI
    08437013457019
    PMA / PMN Number
    BP170154
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE GENOMIC DNA SAMPLE WAS SENT TO GRIFOLS IH CENTER FOR NEXT GENERATION SEQUENCING OF KEL PROXIMAL PROMOTER AND EXONS 1 TO 19. THE SPLICING VARIANT C.1315-2A>G (NOT PREVIOUSLY REPORTED) IN HETEROZYGOUS WAS DETECTED, BASED ON COMMONLY USED SPLICING PREDICTION SOFTWARE; THIS VARIANT WOULD ABOLISH THE HIGHLY CONSERVED SPLICE ACCEPTOR SITE CONSENSUS SEQUENCE AND WOULD LEAD TO AN ABNORMALY SPLICED MRNA AND A NON-FUNCTIONAL PROTEIN. ID CORE XT PREDICTED GENOTYPE RESULT FOR THIS SAMPLE WAS KEL K_KPB_JSB,KEL K_KPB_JSB, BUT ACCORDING TO THE SEQUENCING RESULT AND THE K (UPPER CASE) NEGATIVE SEROLOGY DATA, THE PREDICTED GENOTYPE IS KEL K (KEL 02), KEL K(1315-2G) (KEL 01.01(1315-2G)) ASSOCIATED WITH A PREDICTED PHENOTYPE K (UPPER CASE) NEGATIVE. ID CORE XT REPORTED A PREDICTED K (UPPER CASE) POSITIVE PHENOTYPE, BUT DUE TO THE PRESENCE OF RARE ALLELE KEL K (1315-2G), NOT INTERROGATED BY ID CORE XT, THE PREDICATED PHENOTYPE IS K (UPPER CASE) NEGATIVE. THIS FALSE POSITIVE RESULT OBTAINED BY ID CORE XT IS CONSIDERED A DISCREPANT RESULT. LIMITATIONS 1 AND 10 DESCRIBED IN THE ID CORE XT PACKAGE INSERT COVERS THIS LIMITATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A POSSIBLE DISCREPANCY. THE SEROLOGICAL PHENOTYPE WAS K (UPPER CASE) NEGATIVE BUT WHEN TESTED WITH ID CORE XT RESULTED PHENOTYPE WAS K (UPPER CASE) POSITIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1411009 ID CORE XT ID CORE XT PEP PROGENIKA BIOPHARMA, S.A 1021720000 0203000023 08437013457019

    Patients

    Seq Age Sex Outcome Treatment
    1