BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPURE LS

    MDR report key: 530167 · Received March 4, 2004

    Report

    Report Number
    2132481-2004-00001
    Event Type
    Malfunction
    Date Received
    March 4, 2004
    Date of Event
    February 5, 2004
    Report Date
    February 5, 2004
    Manufacturer
    GENTRA SYSTEMS, INC.
    Product Code
    LXG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CLOG IN WASTE TUBING AND BLOCK CAUSED BACKUP OF HUMAN BLOOD WASTE AND SPILLAGE THAT BROKE CONTAINMENT PROVIDED BY THE INSTRUMENT. SAMPLES WERE NOT COMPROMISED, USERS WERE IN NO IMMEDIATE DANGER, BUT POTENTIAL FOR BLOOD EXPOSURE EXISTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOPURE LS AUTOMATED NUCLEIC ACID PURIFICATION SYSTEM LXG GENTRA SYSTEMS, INC. AP-0096 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *