BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSITITRE GRAM NEGATIVE IVD AST SENSITITRE PLATE

    MDR report key: 20866277 · Received December 5, 2024

    Report

    Report Number
    MW5163355
    Event Type
    Malfunction
    Date Received
    December 5, 2024
    Report Date
    April 30, 2025
    Manufacturer
    TREK DIAGNOSTIC SYSTEMS, LTD.
    Product Code
    JWY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 4/30/2025 FOR REPORT MW5163355 TO UPDATE THE PROCODE.

    Description of Event or Problem · 0

    THERMO SCIENTIFIC GRAM NEGATIVE IVD AST SENSITITRE PLATE, URGENT MEDICAL DEVICE CORRECTION ISSUED OCTOBER 2022 STILL HAS NOT BEEN RESOLVED AND MANUFACTURER DOES NOT RESPOND TO REQUESTS FOR UPDATES. CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) AR ISOLATE 0057 TESTS FALSELY SUSCEPTIBLE ON THE SENSITITRE GRAM NEGATIVE PANEL FOR THE FOLLOWING ANTIBIOTICS: CEFEPIME, ERTAPENEM, MEROPENEM, PIPERACILLIN/TAZOBACTAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1679048 SENSITITRE GRAM NEGATIVE IVD AST SENSITITRE PLATE MANUAL ANTIMICROBIAL SUSCEPTIBILITY TEST SYSTEMS JWY TREK DIAGNOSTIC SYSTEMS, LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown