BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID CORE XT

    MDR report key: 10577295 · Received September 23, 2020

    Report

    Report Number
    3006413195-2020-00020
    Event Type
    Malfunction
    Date Received
    September 23, 2020
    Date of Event
    July 23, 2020
    Report Date
    September 23, 2020
    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
    KU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE GENOMIC DNA SAMPLE WAS SENT TO (B)(6) FOR BI-DIRECTIONAL SEQUENCING. SEQUENCING INTERROGATED JK GENE EXONS 3 TO 10, AND THE GENOTYPE JK*B (588G,956T) HOMOZYGOUS WAS IDENTIFIED. THE ALLELE JK*B(956T) IS A NULL ALLELE REPORTED BY ISBT, JK*02N.08. HENCE, THE GENOTYPE RESULT JK*B(588G,956T) HOMOZYGOUS WITH A PREDICTED JKB- PHENOTYPE IS IN CONCORDANCE WITH THE SEROLOGY RESULT, JKB-. ID CORE XT REPORTED A PREDICTED JKB+ PHENOTYPE, BUT JK*B(956T) NULL ALLELE, NOT INTERROGATED BY ID CORE XT, IS FOUND ASSOCIATED WITH A JKB- 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 JKB, AND THE ID CORE XT GENOTYPE SUGGESTED A PHENOTYPE OF JKB+.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1042025 ID CORE XT ID CORE XT PEP PROGENIKA BIOPHARMA S.A. 1020220034 0203000018

    Patients

    Seq Age Sex Outcome Treatment
    1