BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID CORE XT

    MDR report key: 23862167 · Received December 22, 2025

    Report

    Report Number
    3006413195-2025-00026
    Event Type
    Malfunction
    Date Received
    December 22, 2025
    Date of Event
    September 26, 2025
    Report Date
    December 17, 2025
    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 DEVICE IS DISTRIBUTED OUTSIDE THE US AND NO GUDID INFORMATION EXISTS.

    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 NEGATIVE (JKB-), WHICH CONTRASTED WITH THE MOLECULAR TYPING PERFORMED ON (B)(6) 2025, USING THE ID CORE XT ASSAY WHICH PROVIDED POSITIVE RESULTS (JKB+), WITH ID CORE XT ANALYSIS SOFTWARE V3.0.2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1942047 ID CORE XT ANTIGEN GENOTYPING TEST PEP PROGENIKA BIOPHARMA, S.A 0203000043 08437013457064

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown