BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID CORE XT

    MDR report key: 11478230 · Received March 12, 2021

    Report

    Report Number
    3006413195-2021-00003
    Event Type
    Malfunction
    Date Received
    March 12, 2021
    Date of Event
    January 15, 2021
    Report Date
    April 25, 2021
    Manufacturer
    PROGENIKA BIOPHARMA, S.A
    Product Code
    PEP
    PMA / PMN Number
    BP170154
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE GENOMIC DNA SAMPLE WAS SENT TO GRIFOLS IH CENTER FOR NEXT GENERATION SEQUENCING OF RH GENE (PROXIMAL PROMOTER, EXONS 1 TO 10 AND PORTIONS OF INTRONS). SEQUENCING FOUND A VARIANT IN RHCE GENE, RHCE: C.486+1G>A. THIS VARIANT IS A NULL ALLELE DESCRIBED IN ISBT DATABASE AS RHCE*CEN.03 (NUMERICAL CODE: RHCE*02N.03) ASSOCIATED WITH A PHENOTYPE C-E-. ID CORE XT REPORTED A PREDICTED C+ PHENOTYPE, BUT THE RHCE*CEN.03 NULL ALLELE, NOT INTERROGATED BY ID CORE XT, IS FOUND ASSOCIATED WITH A C NEGATIVE PHENOTYPE. THIS FALSE POSITIVE RESULT OBTAINED BY ID CORE XT IS CONSIDERED A DISCREPANT RESULT. THIS LIMITATION IS COVERED BY THE GENERAL ASSAY LIMITATIONS DESCRIBED IN THE ID CORE XT PACKAGE INSERT (LIMITATIONS 1 AND 10).

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL ON-GOING. NO CONCLUSION IS AVAILABLE FOR THIS MALFUNCTION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A POSSIBLE DISCREPANCY. THE SEROLOGICAL PHENOTYPE WAS C-, C+ AND THE ID CORE XT GENOTYPE SUGGESTED A PHENOTYPE OF C+, C+.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369853 ID CORE XT ID CORE XT PEP PROGENIKA BIOPHARMA, S.A 1020220034 0203000021

    Patients

    Seq Age Sex Outcome Treatment
    1