BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERAX PLATELET PGD TEST

    MDR report key: 7977033 · Received October 18, 2018

    Report

    Report Number
    7977033
    Event Type
    Malfunction
    Date Received
    October 18, 2018
    Date of Event
    October 4, 2018
    Report Date
    October 11, 2018
    Manufacturer
    VERAX BIOMEDICAL INCORPORATED
    Product Code
    MZC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    VERAX PLATELET PAN GENARA DETECTION (PGD) TESTING IS PERFORMED ON NON-PATHOGEN REDUCED PLATELETS FOR THE DETECTION OF BACTERIA. THE TEST IS MANUFACTURED BY VERAX BIOMEDICAL AND IS FDA APPROVED FOR THE RAPID -DETECTION OF BACTERIAL CONTAMINATION OF PLATELET PRODUCTS. PLATELET PRODUCTS THAT HAVE NOT BEEN PATHOGEN REDUCED AND ARE STILL IN INVENTORY ON DAYS 4 AND 5 AFTER COLLECTION ARE TESTED FOR BACTERIAL CONTAMINATION USING THE VERAX PGD TEST KIT. LAST WEEK, TWO STEM CELL TRANSPLANT PATIENTS RECEIVED BACTERIALLY CONTAMINATED PLATELET. THE PLATELET PRODUCTS WERE TESTED FOR BACTERIAL CONTAMINATION (VERAX PGD) ON DAY 4 AND THE RESULTS WERE (B)(6). PATIENT WAS TRANSFUSED AT THE SAME LOCATION. THE TESTING WAS PERFORMED AND CULTURES REPORTS (B)(6) FOR ACINETOBACTER BAUMANNII.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819157 VERAX PLATELET PGD TEST SYSTEM, DETECTION, BACTERIAL, FOR PLATELET TRANSFUSION PRODUCTS MZC VERAX BIOMEDICAL INCORPORATED REAGENT1-L10026, L10028, L1003

    Patients

    Seq Age Sex Outcome Treatment
    1