BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIONOVA BT220

    MDR report key: 19590490 · Received June 21, 2024

    Report

    Report Number
    3013145340-2024-00025
    Event Type
    Malfunction
    Date Received
    June 21, 2024
    Date of Event
    June 8, 2021
    Report Date
    June 21, 2024
    Manufacturer
    TERRAGENE S.A.
    Product Code
    FRC
    UDI-DI
    07798164670247
    PMA / PMN Number
    K163646
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NO ADVERSE EVENT REPORTED. MOST PROBABLE CAUSE OF THE NEGATIVE RESULTS IS MISUSE BY THE USER.

    Description of Event or Problem · 0

    FALSE NEGATIVE RESULT. NOT ENOUGH EVIDENCE FOR MISUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1280699 BIONOVA BT220 BIOLOGICAL INDICATOR FRC TERRAGENE S.A. BIONOVA BT220 A10028 07798164670247

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown