BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID CORE XT

    MDR report key: 21729293 · Received March 31, 2025

    Report

    Report Number
    3006413195-2025-00005
    Event Type
    Malfunction
    Date Received
    March 31, 2025
    Date of Event
    February 27, 2025
    Report Date
    March 30, 2025
    Manufacturer
    PROGENIKA BIOPHARMA, S.A.
    Product Code
    PEP
    UDI-DI
    08437013457019
    PMA / PMN Number
    BP170154
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SAMPLE (B)(6) FROM "MAYO CLINIC RECEIVING HUB" WAS TESTED WITH SEROLOGY. THE TEST RESULT WAS JKB POSITIVE (JKB+) WHICH CONTRASTED WITH THE MOLECULAR TYPING PERFORMED WITH ID CORE XT ON (B)(6) 2025, WHICH PROVIDED JKB NEGATIVE (JKB-) RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    913209 ID CORE XT ANTIGEN GENOTYPING TEST PEP PROGENIKA BIOPHARMA, S.A. 0203000039 08437013457019

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown