BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID CORE XT

    MDR report key: 19872193 · Received July 31, 2024

    Report

    Report Number
    3006413195-2024-00011
    Event Type
    Malfunction
    Date Received
    July 31, 2024
    Date of Event
    May 14, 2024
    Report Date
    July 29, 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 RESULTS ARE PENDING DUE TO THE DELAYED AVAILABILITY OF THE SAMPLE FOR THE STUDY. ON (B)(6) 2024 THE SAMPLE WAS SENT TO TO GRIFOLS LABORATORY SOLUTIONS FOR DNA SEQUENCING.

    Additional Manufacturer Narrative · 0

    THE GENOMIC DNA SAMPLE WAS SENT TO GRIFOLS LABORATORY SOLUTIONS FOR SEQUENCING. NEXT GENERATION SEQUENCING INTERROGATED RH GENES PROXIMAL PROMOTER, EXONS 1-10, AND PORTIONS OF INTRON 2-3. THE GENOTYPE OBTAINED BY SEQUENCING WAS RHCE*CE, RHCE*CE, WHICH IS DISCREPANT WITH ID CORE XT RESULT, RHCE*CE, RHCE*CE. A DETAILED READ ANALYSIS OF NGS RESULTS INDICATED THE PRESENCES OF 2% OF RHCE*C SEQUENCE WHICH EXPLAINS THE ID CORE XT RESULT, PS88 (LITTLE C) GENOTYPE PRESENT. THE SUBJECT OF THIS SAMPLE IS A PATIENT DIAGNOSED WITH A CHRONIC LYMPHOPROLIFERATIVE DISORDER. THIS CONDITION MAY EXPLAIN A MIXED FIELD GENOTYPE IN THE BLOOD SAMPLE, DETECTED BY ID CORE XT. FOR A DEFINITIVE DETERMINATION OF THE PATIENT'S GENOTYPE AND PREDICTED PHENOTYPE, ANALYSIS OF A SALIVA SAMPLE IS ADVISED. WHILE ID CORE XT PREDICTED A C+ PHENOTYPE, THE SEQUENCING RESULTS, COUPLED WITH SEROLOGY DATA INDICATING A C NEGATIVE, SUGGEST THE PHENOTYPE IS INDEED C NEGATIVE. THIS FALSE POSITIVE RESULT OBTAINED BY ID CORE XT IS CONSIDERED A DISCREPANT RESULT AND THEN A MALFUNCTION. THIS SITUATION IS COVERED BY THE LIMITATION 13 OF THE PACKAGE INSERT OF ID CORE XT: "PATIENTS WITH SOME TYPES OF LEUKEMIA COULD LEAD TO INACCURATE RESULTS BY ID CORE XT. THE HEMATOLOGIC MALIGNANCIES MAY CAUSE MIXED TYPES OF BLOOD WHITE CELLS DUE TO HEMATOPOIETIC STEM CELL TRANSPLANTATION (HSCT); UNBALANCED CHROMOSOME ABERRATIONS; LOSS OF HETEROZYGOSITY DUE TO HEMATOPOIETIC MOSAICISM OR OTHER RARE EVENTS. IN THESE CASES, THE USE OF SALIVA SAMPLES IS RECOMMENDED TO OBTAIN ACCURATE RESULTS".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SAMPLE 174 24 VF, FROM "FARM. OSP. S. CAMILLO -ROMA", WAS TESTED WITH SEROLOGY. THE TEST RESULT WAS NEGATIVE (C-), WHICH CONTRASTED WITH MOLECULAR TYPING USING BIOARRAY PRODUCTS AND ID CORE XT ASSAY PERFORMED ON (B)(6) 2024, WHICH PROVIDED A POSITIVE RESULT (C+).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    912695 ID CORE XT ANTIGEN GENOTYPING TEST PEP PROGENIKA BIOPHARMA, S.A 0203000031

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown