BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMEL

    MDR report key: 24176882 · Received January 26, 2026

    Report

    Report Number
    24176882
    Event Type
    Malfunction
    Date Received
    January 26, 2026
    Date of Event
    December 30, 2025
    Report Date
    January 6, 2026
    Manufacturer
    REMEL, INC.
    Product Code
    JSJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SPECIFIC AGAR PLATE USED WITHIN THE LABORATORY GREW A MOLD NOT REPRESENTATIVE OF THE PATIENT'S CULTURE. THE SAME MOLD WAS RECOVERED ON ADDITIONAL PLATES OF THE SAME LOT FROM DIFFERENT PATIENTS AND COLLECTION LOCATIONS, INDICATING CONTAMINATION FROM THE MANUFACTURER. UNFORTUNATELY, THERE IS NOT AN INSTRUMENT REPORT GENERATED. MOLD IDENTIFICATION IS MANUAL METHOD BASED ON TECHNOLOGIST MICROSCOPY. THE MOLD WAS IDENTIFIED PER OUR INTERNAL PROTOCOLS FOR FUNGI IDENTIFICATION. ENVIRONMENTAL CONCERN HAS BEEN RULED OUT AND NO OTHER PRODUCTS IN OUR LAB HAVE BEEN IDENTIFIED AS IMPACTED. ERRONEOUS LAB RESULTS REDACTED FROM PATIENT CHARTS. THIS TEAM NOTIFIED REP VIA EMAIL AND PHONE OF THE ISSUE, INCLUDING MEDWATCH REPORT NUMBER AND ALL DETAILS FROM THIS REPORT. MANUFACTURER RESPONSE FOR AGAR PLATE, (BRAND NOT PROVIDED) (PER SITE REPORTER). WAITING TO HEAR IF SAMPLE IS AVAILABLE AND IF REP WOULD LIKE IT SENT TO THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240621 REMEL CULTURE MEDIA, SELECTIVE AND NON-DIFFERENTIAL JSJ REMEL, INC. R01341 342114

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown