BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID CORE XT

    MDR report key: 9438777 · Received December 9, 2019

    Report

    Report Number
    3006413195-2019-00013
    Event Type
    Malfunction
    Date Received
    December 9, 2019
    Date of Event
    September 30, 2019
    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
    SP
    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 3 TO 10 AND THE FOLLOWING ALLELE GENOTYPE WAS IDENTIFIED JKA*(588A), JK*B(832C). VARIANT JK*C.588G>A IS A PUBLISHED SILENT VARIANT, P.196 PRO/PRO (ERYTHROGENE DATABASE. 2016 BLOOD ADVANCES VOL.1 P.240). VARIANT JK*C.832T>C HAS NOT BEEN PREVIOUSLY REPORTED. THE PRESENCE OF UNPUBLISHED JK*C.832T>C VARIANT IN ID CORE XT PROBES WHICH DETECT JKB ANTIGEN PREVENTS HYBRIDIZATION AND CONSEQUENTLY THE PREDICTION OF JKB POSITIVE ANTIGEN. ID CORE XT REPORTED A PREDICTED JKB NEGATIVE PHENOTYPE DUE TO THE PRESENCE OF JK*C.832T>C VARIANT WHICH CAUSES AN ALLELE-DROP OUT, BEING THE PHENOTYPE JKB POSITIVE. THIS FALSE NEGATIVE RESULT OBTAINED BY ID CORE XT IS CONSIDERED A DISCREPANT RESULT AND THEN A MALFUNCTION. THIS CASE REPORT IS ASSOCIATED WITH A NEW LIMITATION OF ID CORE XT ASSAY.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1232071 ID CORE XT ID CORE XT PEP PROGENIKA BIOPHARMA S.A. 1020220034 0203000018

    Patients

    Seq Age Sex Outcome Treatment
    1