BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID CORE XT

    MDR report key: 9438612 · Received December 9, 2019

    Report

    Report Number
    3006413195-2019-00002
    Event Type
    Malfunction
    Date Received
    December 9, 2019
    Date of Event
    December 17, 2018
    Report Date
    December 9, 2019
    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
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE GENOMIC DNA SAMPLE WAS SENT TO (B)(4) FOR BI-DIRECTIONAL SEQUENCING. SEQUENCING INTERROGATED JK GENE EXONS 4 TO 11 AND THE ALLELE GENOTYPE JK*A(588A,1111A), JK*B WAS IDENTIFIED. VARIANT JK*C.588 G>A IS A PUBLISHED SILENT VARIANT, P.196 PRO/PRO (ERYTHROGENE DATABASE. 2016 BLOOD ADVANCES VOL.1 P.240). VARIANT JK*C.1111G>A WAS NOT PREVIOUSLY REPORTED, BUT THIS VARIANT ENCODES AN AMINO ACID CHANGE, P.371GLU>LYS. SEROLOGY RESULTS FOR THIS SAMPLE IS JKA NEGATIVE. HENCE, THE JK*A(1111A) VARIANT ALLELE IS A JK NULL ALLELE THAT SHOULD BE LOCATED ON JK*A ALLELE PREVENTING JKA EXPRESSION. ID CORE XT REPORTED A PREDICTED JKA+ PHENOTYPE, BUT JK*A(1111A) VARIANT ALLELE, NOT INTERROGATED BY ID CORE XT, IS ASSOCIATED WITH A JKA NEGATIVE PHENOTYPE. THIS FALSE POSITIVE RESULT OBTAINED BY ID CORE XT IS CONSIDERED A DISCREPANT RESULT AND THEN A MALFUNCTION. THIS CASE REPORT IS COVERED BY LIMITATIONS NUMBER 1 AND 10 OF ID CORE XT PACKAGE INSERT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A POSSIBLE DISCREPANCY. THE SAMPLE IS JKA+ USING ID CORE XT ASSAY BUT SEROLOGY REPORTED JKA-.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1232924 ID CORE XT ID CORE XT PEP PROGENIKA BIOPHARMA S.A. 1020220034 0203000013

    Patients

    Seq Age Sex Outcome Treatment
    1