BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID CORE XT

    MDR report key: 9438729 · Received December 9, 2019

    Report

    Report Number
    3006413195-2019-00012
    Event Type
    Malfunction
    Date Received
    December 9, 2019
    Date of Event
    September 18, 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 JK*A(130A, 190T),JK*B(130A). JK*A(130A) VARIANT ALLELE IS A WEAK ALLELE REPORTED BY ISBT AS JK*01W.01. PLACEMENT ON JK*A OR JK*B ALLELE OF VARIANT JK*C.190T IS UNKNOWN (2015 VOX SANGUINIS VOL.109 SUPPL.1 P.286 P-584). JK*B(130A) VARIANT ALLELE HAS NOT BEEN PREVIOUSLY REPORTED. THE SEROLOGY RESULT OF THIS SAMPLE JKA-,JKB+ SUGGEST THAT JK*A(130A, 190T) VARIANT ALLELE AFFECT TO THE EXPRESSION OF JKA ANTIGEN. ID CORE XT REPORTED A PREDICTED JKA+ PHENOTYPE, BUT JK*A(130A,190T) VARIANT ALLELE, NOT INTERROGATED BY ID CORE XT, IS ASSOCIATED WITH JKA NEGATIVE PHENOTYPE. THE 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+,JKB+ USING ID CORE XT ASSAY BUT SEROLOGY REPORTED JKA-,JKB+.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1230824 ID CORE XT ID CORE XT PEP PROGENIKA BIOPHARMA S.A. 1020220034 0203000018

    Patients

    Seq Age Sex Outcome Treatment
    1