BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOPURE LS

    MDR report key: 514180 · Received March 4, 2004

    Report

    Report Number
    2132481-2004-00002
    Event Type
    Injury
    Date Received
    March 4, 2004
    Date of Event
    February 6, 2004
    Report Date
    February 10, 2004
    Manufacturer
    GENTRA SYSTEMS, INC.
    Product Code
    LXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SUBCONTRACTED SERVICE ENGINEER INJURED THEMSELVES WHILE REPAIRING DEVICE. SINCE THE DEVICE PROCESSES BIOLOGICAL SAMPLES, INCLUDING HUMAN BLOOD, AND POTENTIAL FOR INFECTION IS EVIDENT. EVENT WAS A USER ERROR AS SUBCONTRACTED ENGINEER HAD NOT BEEN FULLY TRAINED BY CONTACT SERVICE GROUP AND DID NOT TAKE NECESSARY PRECAUTIONS WHILE PERFORMING SERVICE FUNCTION. NO MACHINE MALFUNCTION OR ACTION CAUSED INJURY. THE SERVICE ENGINEER HAS BEEN PROVIDED WITH ONGOING PRECAUTIONARY MEDICAL TREATMENT AND EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOPURE LS AUTOMATED NUCLEIC ACID PURIFICATION SYSTEM LXG GENTRA SYSTEMS, INC. AP-0097 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other