BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID CORE XT

    MDR report key: 20378811 · Received October 5, 2024

    Report

    Report Number
    3006413195-2024-00015
    Event Type
    Malfunction
    Date Received
    October 5, 2024
    Date of Event
    August 21, 2024
    Report Date
    October 5, 2024
    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 FROM "LIFESOUTH COMMUNITY BLOOD CENTER" THAT TWO SAMPLES (B)(6) FROM THE SAME PATIENT WERE TESTED USING ID CORE XT ASSAY. THE MIA RESULTS OF THESE TESTS WERE DISCREPANT. ONE TEST PERFORMED ON (B)(6) 2023 WITH SAMPLE (B)(6) SHOWED A NEGATIVE RESULT FOR MIA (MIA-) WHILE THE OTHER TEST CONDUCTED ON 21AUG24 WITH SAMPLE (B)(6) SHOWED A POSITIVE RESULT (MIA+). IN BOTH CASES, THE MIA PROBE RATIO EXHIBITED AN UNUSUAL AND ALTERED SIGNAL RATIOS. ALL GENOTYPE AND PHENOTYPE RESULTS WERE PROVIDED BY THE ID CORE XT ANALYSIS SOFTWARE V3.0.5.1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1403231 ID CORE XT ANTIGEN GENOTYPING TEST PEP PROGENIKA BIOPHARMA, S.A 0203000036 08437013457019

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown