BEUDAMED
    FDA Adverse Event Other Summary report: N

    AUTO-LIPA

    MDR report key: 822824 · Received February 16, 2007

    Report

    Report Number
    2432235-2007-00004
    Event Type
    Other
    Date Received
    February 16, 2007
    Date of Event
    January 9, 2007
    Report Date
    January 17, 2007
    Manufacturer
    INNOGENETICS N.V.
    Product Code
    LXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2007, THE MFR WAS RUNNING THEIR OWN HIV WESTERN BLOT (GENETIC SYSTEMS) ON THE AUTO-LIPA 30 (OPEN SYSTEM), WHEN THE OPERATOR NOTICED LIQUID POOLING AT THE BOTTOM OF THE INSTRUMENT. SHE NOTICED THAT THE WASTE TUBING WAS DISCONNECTED FROM A FITTING. FIELD SERVICE WAS NOTIFIED AND AN ENGINEER WAS SENT TO THE SITE. IN THE MEANTIME, THE OPERATOR RE-ATTACHED THE TUBING ON HER OWN AND WAS OBSERVING THE TUBING DURING SYSTEM OPERATION WHEN IT BURST AWAY FROM THE FITTING. SHE WAS SPLASHED IN THE FACE WITH SOME WASTE FLUID. THE OPERATOR WAS WEARING APPROPRIATE PERSONAL PROTECTION (E.G, PROTECTIVE EYE GLASSES) AT THE TIME OF THE INCIDENT. SINCE THE WASTE LIQUID IS A POTENTIAL BIOHAZARD, THE OPERATOR HAS BEEN TESTED FOR HIV, HEPATITIS B, AND HEPATITIS C ANTIBODIES (NEGATIVE RESULTS TO DATE). THE PROBLEM WAS LATER DETERMINED TO BE A FAULTY WASTE PINCH VALVE THAT WAS REPLACED. THIS EVENT IS BEING REPORTED BECAUSE IT OCCURRED IN A BIOHAZARDOUS ENVIRONMENT. FOR MEDICAL DEVICE REPORTING, THIS EVENT IS CONSIDERED CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTO-LIPA GENERAL LABORATORY EQUIPMENT LXG INNOGENETICS N.V. AUTO-LIPA 30 *

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other