BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID CORE XT

    MDR report key: 10485401 · Received September 2, 2020

    Report

    Report Number
    3006413195-2020-00014
    Event Type
    Malfunction
    Date Received
    September 2, 2020
    Date of Event
    July 17, 2020
    Report Date
    September 2, 2020
    Manufacturer
    PROGENIKA BIOPHARMA S.A.
    Product Code
    PEP
    UDI-DI
    08437013457019
    PMA / PMN Number
    BP170154
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE GENOMIC DNA SAMPLE WAS SENT TO GRIFOLS IH CENTER FOR SEQUENCING. NEXT GENERATION SEQUENCING OF KEL EXONS 1-19 WAS CARRIED OUT AND THE VARIANT KEL:C.223+1A WAS IDENTIFIED. THE VARIANT KEL:C.223+1A IS ASSOCIATED WITH ALLELE KEL*K(223+1A) DESCRIBED BY ISBT AS KELL NULL ALLELE PHENOTYPE (KEL*02N.06). ID CORE XT REPORTED A PREDICTED KPB+ PHENOTYPE, BUT KEL:C.223+1A, VARIANT NOT INTERROGATED BY ID CORE XT, IS ASSOCIATED WITH KPB- PHENOTYPE. THIS FALSE POSITIVE RESULT OBTAINED BY ID CORE XT IS 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

    THE CUSTOMER REPORTED A POSSIBLE DISCREPANCY. THE SEROLOGICAL PHENOTYPE WAS KPB- AND THE ID CORE XT GENOTYPE SUGGESTED A PHENOTYPE OF KPB+.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    947508 ID CORE XT ID CORE XT PEP PROGENIKA BIOPHARMA S.A. 1021720000 0203000019 08437013457019

    Patients

    Seq Age Sex Outcome Treatment
    1