BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID CORE XT

    MDR report key: 11721912 · Received April 25, 2021

    Report

    Report Number
    3006413195-2021-00004
    Event Type
    Malfunction
    Date Received
    April 25, 2021
    Date of Event
    September 22, 2020
    Report Date
    June 14, 2021
    Manufacturer
    PROGENIKA BIOPHARMA, S.A
    Product Code
    PEP
    PMA / PMN Number
    BP170154
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: CONCLUSION: THE GENOMIC DNA SAMPLE WAS SENT TO GRIFOLS IH CENTER FOR NEXT GENERATION SEQUENCING OF JK PROXIMAL PROMOTER AND EXONS 1 TO 10. THE VARIANTS DETECTED IN HOMOZYGOUS WERE: JK:C.191G>A; JK:C.588A>G AND JK:C.838G>A AND THE GENOTYPE JK*B (191A, 588G) WAS IDENTIFIED. THE ALLELE JK*B (191A) IS A NULL ALLELE REPORTED BY ISBT IN JK*B ALLELE BACKGROUND, JK*02N.09, ASSOCIATED TO JKB NEGATIVE PHENOTYPE IN CONCORDANCE WITH SEROLOGY RESULTS. ID CORE XT REPORTED A PREDICTED JKB+ PHENOTYPE, BUT JK*B (191A, 588G) ALLELE, NOT INTERROGATED BY ID CORE XT, IS ASSOCIATED WITH A JKB NEGATIVE PHENOTYPE. THIS FALSE POSITIVE RESULT OBTAINED BY ID CORE XT IS CONSIDERED A DISCREPANT RESULT AND THEN A MALFUNCTION THIS LIMITATION IS SPECIFICALLY COVERED BY LIMITATION 10.2 DESCRIBED IN THE ID CORE XT PACKAGE INSERT.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL ON-GOING. NO CONCLUSION IS AVAILABLE FOR THIS MALFUNCTION.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617979 ID CORE XT ID CORE XT PEP PROGENIKA BIOPHARMA, S.A 1020220034 0203000019

    Patients

    Seq Age Sex Outcome Treatment
    1