BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABBOTT M2000SP INSTRUMENT

    MDR report key: 1364018 · Received January 15, 2009

    Report

    Report Number
    3005248192-2009-00001
    Event Type
    Other
    Date Received
    January 15, 2009
    Date of Event
    November 14, 2008
    Report Date
    December 22, 2008
    Manufacturer
    ABBOTT MOLECULAR
    Product Code
    KEY
    PMA / PMN Number
    BP060002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A LAB TECH MAY HAVE BEEN EXPOSED TO BIOHAZARD MATERIAL WHILE CLEANING THE M200SP INSTRUMENT (B) (4) WHEN HIS GLOVE WAS TORN. SPECIFICALLY, A LAB TECH WAS CLEANING THE M2000SP AND HE GRAZED HIS GLOVED HAND ACROSS THE ROMA ARM OF THE M2000SP INSTRUMENT. THE GLOVE WAS TORN AND THE GRAZE BLED SLIGHTLY, MINUTES AFTER THE INCIDENT. A PLASTER (BANDAID) WAS APPLIED. SINCE THE TIME OF THE INCIDENT, THE GRAZE HAS HEALED. THERE WAS NO FEVER ASSOCIATED WITH THIS INCIDENT. THE PT STATES THAT THERE ARE NO PLANS TO MONITOR HIM FOR (B) (6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT M2000SP INSTRUMENT SAMPLE EXTRACTION DEVICE KEY ABBOTT MOLECULAR 9K14-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Other