BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID CORE XT

    MDR report key: 9438723 · Received December 9, 2019

    Report

    Report Number
    3006413195-2019-00009
    Event Type
    Malfunction
    Date Received
    December 9, 2019
    Date of Event
    April 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
    TH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE GENOMIC DNA SAMPLE WAS SENT TO (B)(4) FOR BI-DIRECTIONAL SEQUENCING. SEQUENCING INTERROGATED KEL GENE EXONS 1 TO 19 AND THE HOMOZYGOUS ALLELE GENOTYPE KEL*K(1216T) WAS IDENTIFIED. THIS VARIANT ALLELE WAS REPORTED BY ISBT AS KEL*02N.15 WHICH ENCODES A NULL KELL PHENOTYPE, K0. THIS KELL PHENOTYPE IS K-, K-, KPA-, KPB-, JSA-, JSB-. ID CORE XT REPORTED A PREDICTED K+, KPB+ PHENOTYPE, BUT NULL KEL*K(1216T) VARIANT ALLELE, NOT INTERROGATED BY ID CORE XT, IS ASSOCIATED WITH K-, KPB- NEGATIVE PHENOTYPE. THE FALSE POSITIVE RESULTS OBTAINED BY ID CORE XT ARE 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 K+, KPB+ USING ID CORE XT ASSAY BUT SEROLOGY REPORTED K-, KPB-.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1230829 ID CORE XT ID CORE XT PEP PROGENIKA BIOPHARMA S.A. 1020220034 0203000014

    Patients

    Seq Age Sex Outcome Treatment
    1