BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID CORE XT

    MDR report key: 23790171 · Received December 12, 2025

    Report

    Report Number
    3006413195-2025-00022
    Event Type
    Malfunction
    Date Received
    December 12, 2025
    Date of Event
    July 21, 2020
    Report Date
    December 12, 2025
    Manufacturer
    PROGENIKA BIOPHARMA, S.A
    Product Code
    PEP
    UDI-DI
    08437013457064
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KU
    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) BLOOD BANK", WAS TESTED USING A MOLECULAR GENOTYPING METHOD (INNO-TRAIN), YIELDING A POSITIVE RESULT (JOA+). THIS CONTRASTS WITH THE ID CORE XT CONDUCTED ON (B)(6) 2020, WHICH PRODUCED A NEGATIVE RESULT (JOA-) WHEN ANALYZED WITH ID CORE XT ANALYSIS SOFTWARE V3.0.2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2758907 ID CORE XT ANTIGEN GENOTYPING TEST PEP PROGENIKA BIOPHARMA, S.A 0203000019 08437013457064

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown