BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOTRACE

    MDR report key: 22119854 · Received May 30, 2025

    Report

    Report Number
    3013145340-2025-00001
    Event Type
    Malfunction
    Date Received
    May 30, 2025
    Date of Event
    April 29, 2025
    Report Date
    May 30, 2025
    Manufacturer
    TERRAGENE S.A.
    Product Code
    FRC
    UDI-DI
    07798375772471
    PMA / PMN Number
    K191021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICE-RELATED DEATHS OR SERIOUS INJURIES WERE INFORMED. THE HISTORICAL RECORD OF THE DEVICE WAS CHECKED AND NO DEVIATIONS WERE FOUND. TERRAGENE REQUESTED THE AUTO-READER TO THE FINAL USER FOR A THOROUGH INSPECTION TO DETERMINE THE CAUSE OF MALFUNCTION. A FOLLOW-UP WILL BE MADE AFTER TERRAGENE RECEIVES THE DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTS THAT THEIR READER COULD NOT REACH THE TEMPERATURE SELECTED. ADDITIONALLY, THE AUTO-READER GAVE OUT FALSE POSITIVE AND FALSE NEGATIVE RESULTS. THE CUSTOMER ALSO NOTES THAT THE TEMPERATURE UNIT IS BEING MISREPRESENTED, SHOWING CELSIUS INSTEAD OF FAHRENHEIT AND VICE VERSA. THERE WAS NO REPORT OF INFECTION, INJURY OR HARM TO PATIENTS OR PROCEDURE DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737004 BIOTRACE AUTO-READER INCUBATOR FRC TERRAGENE S.A. BIOTRACE AUTO READ PRO BIOLOGICAL INDICATOR READER 2424 07798375772471

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown