BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID CORE XT

    MDR report key: 17265310 · Received July 6, 2023

    Report

    Report Number
    3006413195-2023-00017
    Event Type
    Malfunction
    Date Received
    July 6, 2023
    Date of Event
    April 12, 2023
    Report Date
    July 6, 2023
    Manufacturer
    PROGENIKA BIOPHARMA, S.A
    Product Code
    PEP
    UDI-DI
    08437013457064
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE GENOMIC DNA SAMPLE WAS SENT TO GRIFOLS LABORATORY SOLUTION FOR DNA SEQUENCING. NEXT GENERATION SEQUENCING INTERROGATED SPECIFIC SEQUENCES: RH PROXIMAL PROMOTER, EXONS 1-10, AND PORTIONS OF INTRON 2-3. THE RH GENOTYPE DETECTED BY SEQUENCING IS A HYBRID SEQUENCE OF RHD EXON2-INTRON2-EXON3 WITHIN RHCE GENE. THIS HYBRID SEQUENCE EXPLAINS THE FAILURE OF ID CORE XT TO DETECT THE 109BP INSERT IN INTRON 2 RESULTING IN A FALSE NEGATIVE PREDICTION OF C ANTIGEN IN DISCREPANCY WITH SEROLOGY RESULT. THE EFFECT OF THIS NOVEL HYBRID ALLELE ON RHCE ANTIGEN EXPRESSION IS UNKNOWN AND FURTHER REVIEW OF SEROLOGY DATA IS RECOMMENDED. THIS FALSE NEGATIVE RESULT OBTAINED BY ID CORE XT IS CONSIDERED A DISCREPANT RESULT AND THEN A MALFUNCTION. THIS CASE REPORT IS ASSOCIATED WITH LIMITATIONS OF ID CORE XT ASSAY DESCRIBED IN THE ID CORE XT PACKAGE INSERT (LIMITATIONS 1 AND 9.7).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SAMPLE (B)(6), FROM "(B)(6)", WAS TESTED WITH SEROLOGY. THE TEST RESULT WAS POSITIVE (C+), WHICH CONTRASTED WITH THE MOLECULAR TYPING PERFORMED ON (B)(6) 2023, USING THE ID CORE XT ASSAY WHICH PROVIDED NEGATIVE RESULTS (C-) WITH ID CORE XT ANALYSIS SOFTWARE V3.0.2. .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    989996 ID CORE XT ANTIGEN GENOTYPING TEST PEP PROGENIKA BIOPHARMA, S.A 0203000029 08437013457064

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown