BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID CORE XT

    MDR report key: 9684626 · Received February 7, 2020

    Report

    Report Number
    3006413195-2020-00001
    Event Type
    Malfunction
    Date Received
    February 7, 2020
    Date of Event
    December 27, 2019
    Report Date
    February 7, 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
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE GENOMIC DNA SAMPLE WAS SENT TO (B)(6) CENTER FOR BI-DIRECTIONAL-SEQUENCING. SEQUENCING INTERROGATED KEL EXONS 1-19 AND THE VARIANT KEL:C.1719C>T WAS IDENTIFIED. THIS VARIANT ALLELE KEL*K(1719T) HAS BEEN VARIOUSLY REPORTED TO ENCODE "NEGATIVE", "MOD", AND "ELUTE PHENOTYPES (2003 TRANSFUSION VOL. 43 P.1121; 2007 TRANSFUSION VOL.47 P.703; 2014 VOX SANGUINIS VOL.106 P.197). THIS VARIANT ALLELE IS DESCRIBED BY ISBT AS KMOD, KEL*02M.05 (MODIFIED EXPRESSION WHICH IS VARIABLE DETECTED DEPENDING ON THE USED REAGENT). ID CORE XT REPORTED A PREDICTED KPB+ PHENOTYPE, BUT KEL:C.1719C>T VARIANT, NOT INTERROGATED BY ID CORE XT, IS ASSOCIATED WITH A KPB NEGATIVE OR MODIFIED 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 LIMITATION DESCRIBED IN THE ID CORE XT PACKAGE INSERT (LIMITATION 1 AND 10).

    Description of Event or Problem · 1

    SITE REPORTS KPB DISCREPANCY BETWEEN ID CORE XT AND SEROLOGY RESULTS. SAMPLE 193625 WAS TESTED BY SEROLOGY 4 TIMES AND IS KP(B-) AND THE GENOTYPE IS POSITIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146984 ID CORE XT ID CORE XT PEP PROGENIKA BIOPHARMA S.A. 1021720000 0203000016

    Patients

    Seq Age Sex Outcome Treatment
    1