BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-SOY BROTH

    MDR report key: 20953259 · Received December 16, 2024

    Report

    Report Number
    MW5163677
    Event Type
    Malfunction
    Date Received
    December 16, 2024
    Date of Event
    November 4, 2024
    Report Date
    December 12, 2024
    Manufacturer
    REMEL, INC.
    Product Code
    JSG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    NUMEROUS PATIENTS WERE IDENTIFIED AS HAVING DISCREPANT MICROBIOLOGY RESULTS. TISSUE SPECIMEN GRAM STAINS WERE REPORTED POSITIVE; GRAM POSITIVE COCCI IN SHORT CHAINS YET THE CULTURES WERE NEGATIVE. AFTER FURTHER INVESTIGATION, IT WAS DETERMINED THAT THE TRYPTIC SOY BROTH (TRYPTIC SOY BROTH) UTILIZED FOR GRAM STAIN PROCESSING WAS CONTAMINATED. THE USE OF ALL SUSPECTED CONTAMINATED TRYPTIC SOY BROTH HAS BEEN DISCONTINUED. THE DISTRIBUTOR HAS BEEN ALERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227474 T-SOY BROTH CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG REMEL, INC. 185090

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other