BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID CORE XT

    MDR report key: 9791311 · Received March 5, 2020

    Report

    Report Number
    3006413195-2020-00006
    Event Type
    Malfunction
    Date Received
    March 5, 2020
    Date of Event
    January 16, 2020
    Report Date
    March 5, 2020
    Manufacturer
    PROGENIKA BIOPHARMA S.A.
    Product Code
    PEP
    PMA / PMN Number
    BP170154
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE GENOMIC DNA SAMPLE WAS SENT TO (B)(4) FOR BI-DIRECTIONAL-SEQUENCING. SEQUENCING INTERROGATED KEL GENE EXONS 1-19 AND THE VARIANT KEL:C.948G>A IN HOMOZYGOUS WAS IDENTIFIED. THIS VARIANT ALLELE KEL*K(948A) IS DESCRIBED BY ISBT AS ONE OF THE REPORTED NULL ALLELES OF KELL SYSTEM (K0), KEL*02N.14, ASSOCIATED WITH NO EXPRESSION OF KELL ANTIGENS. ID CORE XT REPORTED A PREDICTED K+, KPB+ AND JSB POSITIVE PHENOTYPE, BUT KEL:C.948G>A VARIANT, NOT INTERROGATED BY ID CORE XT, IS ASSOCIATED WITH K-, KPB- AND JSB- PHENOTYPE. THOSE FALSE POSITIVE RESULTS OBTAINED BY ID CORE XT ARE CONSIDERED A DISCREPANT RESULT AND THEN A MALFUNCTION. THIS LIMITATION IS COVERED BY THE GENERAL ASSAY LIMITATIONS DESCRIBED IN THE ID CORE XT PACKAGE INSERT (LIMITATIONS 1 AND 10).

    Description of Event or Problem · 1

    BLOODCHIP IDENTYS KEL*K_KPB_JSB IN A SAMPLE WHITH A POSSIBLE PHENOTYPE WOULD BE KO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255913 ID CORE XT ID CORE XT PEP PROGENIKA BIOPHARMA S.A. 1020220034 0203000018

    Patients

    Seq Age Sex Outcome Treatment
    1