BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PAXGENE® BLOOD RNA TUBE

    MDR report key: 7532194 · Received May 22, 2018

    Report

    Report Number
    9617032-2018-01272
    Event Type
    Malfunction
    Date Received
    May 22, 2018
    Date of Event
    October 16, 2017
    Report Date
    June 7, 2018
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    NTW
    PMA / PMN Number
    DEN050003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE 510(K)# WAS CHANGED TO DEN050003.

    Additional Manufacturer Narrative · 1

    (B)(6). BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT AND NO ISSUES WERE IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PAXGENE® BLOOD RNA TUBES WERE GIVING ERRONEOUS RESULTS (LOWER RIN VALUES). HOWEVER IT SHOULD BE NOTED THAT THE TUBES WERE EXPIRED WHEN USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378200 PAXGENE® BLOOD RNA TUBE RNA PREANALYTICAL SYSTEMS NTW BECTON, DICKINSON AND COMPANY (BD) 4244464

    Patients

    Seq Age Sex Outcome Treatment
    1 Other