BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID CORE XT

    MDR report key: 12878198 · Received November 26, 2021

    Report

    Report Number
    3006413195-2021-00015
    Event Type
    Malfunction
    Date Received
    November 26, 2021
    Date of Event
    October 13, 2021
    Report Date
    November 26, 2021
    Manufacturer
    PROGENIKA BIOPHARMA, S.A
    Product Code
    PEP
    UDI-DI
    08437013457019
    PMA / PMN Number
    BP170154
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A MALFUNCTION OF ID CORE XT. SEROLOGY PHENOTYPE: K (UPPER CASE) (B)(6), K (B)(6); ID CORE XT PHENOTIPE: K (UPPER CASE) (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1776765 ID CORE XT ANTIGEN GENOTYPING TEST PEP PROGENIKA BIOPHARMA, S.A v3 0203000023 08437013457019

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown