BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID CORE XT

    MDR report key: 10341883 · Received July 29, 2020

    Report

    Report Number
    3006413195-2020-00010
    Event Type
    Malfunction
    Date Received
    July 29, 2020
    Date of Event
    June 27, 2020
    Report Date
    June 29, 2020
    Manufacturer
    PROGENIKA BIOPHARMA S.A.
    Product Code
    PEP
    UDI-DI
    08437013457019
    PMA / PMN Number
    BP170154
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE GENOMIC DNA SAMPLE WAS SENT TO GRIFOLS IH CENTER FOR SEQUENCING. NEXT GENERATION SEQUENCING INTERROGATED RH GENES PROXIMAL PROMOTER, EXONS 1-10, AND PORTIONS OF INTRON 2-3. NO VARIANT WAS FOUND IN RH GENES AND SEQUENCING PROVIDED A GENOTYPE RHCE*CE, RHCE*CE, BUT ID CORE XT REPORTED A GENOTYPE RHCE*CE, RHCE*CE. ID CORE XT DETERMINES C/C ANTIGENS INTERROGATING POLYMORPHISM RHCE: C.335+3039INS109 IN RHCE GENE INTRON 2. THE PRESENCE OF THE 109 BP INSERT IS ASSOCIATED WITH C ANTIGEN. HOWEVER, THIS SAMPLE CARRIES A RARE ALLELE DESCRIBED BY ISBT AS RHCE*02.37 THAT PROVIDES A C+ PHENOTYPE BY LACKS THE 109 BP INSERT. ID CORE XT REPORTED A PREDICTED C- PHENOTYPE, BUT THE SEROLOGY DATA FROM THE USER IS C+, DUE TO THE PRESENCE OF RARE RHCE*02.37 ALLELE. SINCE ID CORE XT OBTAINED A FALSE NEGATIVE RESULT, THIS 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).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A POSSIBLE DISCREPANCY. THE SEROLOGICAL PHENOTYPE WAS C POSITIVE AND THE ID CORE XT GENOTYPE SUGGESTED A PHENOTYPE OF C NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801862 ID CORE XT ID CORE XT PEP PROGENIKA BIOPHARMA S.A. 1021720000 0203000019 08437013457019

    Patients

    Seq Age Sex Outcome Treatment
    1