BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID CORE XT

    MDR report key: 19872143 · Received July 31, 2024

    Report

    Report Number
    3006413195-2023-00021
    Event Type
    Malfunction
    Date Received
    July 31, 2024
    Date of Event
    October 24, 2023
    Report Date
    July 31, 2024
    Manufacturer
    PROGENIKA BIOPHARMA, S.A
    Product Code
    PEP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE GENOMIC DNA SAMPLES FROM A FAMILY CASE WERE SENT TO GRIFOLS LABORATORY SOLUTIONS FOR DNA SEQUENCING. THE SEQUENCING RESULTS OF GYPA EXONS 1-7; GYPB EXONS 1-6 AND GYPE EXONS 1-6 IN THE THREE SAMPLES WERE CONSISTENT WITH ID CORE XT RESULTS. NO VARIANTS WERE FOUND IN ANY OF THE SAMPLES THAT EXPLAIN THE DISCREPANCIES WITH SEROLOGY RESULTS. SINCE THE SEQUENCING RESULTS AGREE WITH ID CORE XT, NO MALFUNCTION IS CONSIDERED FOR ID CORE XT. THE SEROLOGY RESULTS ARE RECOMMENDED TO BE FURTHER INVESTIGATED.

    Description of Event or Problem · 0

    IT WAS REPORTED A DISCREPANT RESULT SEROLOGY VS MOLECULAR BIOLOGY IN A FAMILIAR STUDY. THREE SAMPLES 804372 (CHILD), 804826 (FATHER) AND 804825 (MOTHER) FROM "RAGUSA SERVIZIO TRASFUSIONALE", WERE TESTED WITH SEROLOGY. THE TEST RESULT WAS M NEGATIVE (M-) FOR CHILD AND FATHER AND M WEAK FOR MOTHER, WHICH CONTRASTED WITH THE MOLECULAR TYPING USING THE ID CORE XT ASSAY WHICH PROVIDED POSITIVE RESULTS (M+), WITH ID CORE XT ANALYSIS SOFTWARE V3.0.2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1215651 ID CORE XT ANTIGEN GENOTYPING TEST PEP PROGENIKA BIOPHARMA, S.A 0203000030

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown