BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID CORE XT

    MDR report key: 20349966 · Received October 2, 2024

    Report

    Report Number
    3006413195-2024-00013
    Event Type
    Malfunction
    Date Received
    October 2, 2024
    Date of Event
    August 9, 2024
    Report Date
    December 23, 2024
    Manufacturer
    PROGENIKA BIOPHARMA, S.A.
    Product Code
    PEP
    UDI-DI
    08437013457064
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SAMPLE (B)(4) FROM 'CROIX ROUGE DE BELGIQUE' WAS TESTED USING A MOLECULAR GENOTYPING METHOD, YIELDING A POSITIVE RESULT (JOA+WK). THIS CONTRASTS WITH THE MOLECULAR TYPING CONDUCTED ON 09-AUG-2024 DURING THE VALIDATION OF ID CORE XT, 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
    1915511 ID CORE XT ANTIGEN GENOTYPING TEST PEP PROGENIKA BIOPHARMA, S.A. 0203000034 08437013457064

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown