BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID CORE XT

    MDR report key: 21075935 · Received January 5, 2025

    Report

    Report Number
    3006413195-2025-00001
    Event Type
    Malfunction
    Date Received
    January 5, 2025
    Date of Event
    November 26, 2024
    Report Date
    February 18, 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
    FL, 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 "LIFESOUTH COMMUNITY BLOOD CENTER" WAS TESTED WITH SEROLOGY. THE TEST RESULT WAS NEGATIVE (S-), WHICH CONTRASTED WITH THE MOLECULAR TYPING PERFORMED ON (B)(6) 2024, USING THE ID CORE XT ASSAY WHICH PROVIDED POSITIVE RESULTS (S+), WITH ID CORE XT ANALYSIS SOFTWARE V3.0.5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1137486 ID CORE XT ANTIGEN GENOTYPING TEST PEP PROGENIKA BIOPHARMA, S.A 0203000039 08437013457019

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown