BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBOTT M2000SP

    MDR report key: 2853092 · Received July 16, 2012

    Report

    Report Number
    3005248192-2012-00019
    Event Type
    Injury
    Date Received
    July 16, 2012
    Date of Event
    June 22, 2012
    Report Date
    June 26, 2012
    Manufacturer
    ABBOTT MOLECULAR, INC.
    Product Code
    JQW
    PMA / PMN Number
    K092705
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BY FAILING TO WEAR PROTECTIVE EYEWEAR, THE LABORATORY TECHNICIAN DID NOT FOLLOW GOOD LABORATORY PRACTICES AND INSTRUCTIONS PROVIDED IN THE M2000SP OPERATIONS MANUAL FOR EMPTYING THE M2000SP LIQUID WASTE CONTAINER. THE M2000SP OPERATIONS MANUAL 200681-105-OCTOBER 2011 CONTAINS THE FOLLOWING LABELING: USER OR FUNCTION - LIQUID WASTE CONTAINER. CAUTION: THE WASTE IS POTENTIALLY INFECTIOUS. USE APPROPRIATE BIOHAZARD PRECAUTIONS. WASTE HANDLING AND DISPOSAL - LIQUID WASTE. WARNING: THE LIQUID WASTE MAY CONTAIN INFECTIOUS AGENTS AND SHOULD BE CONSIDERED POTENTIALLY INFECTIOUS WASTE. DAILY MAINTENANCE: SERVICE AND MAINTENANCE - EMPTY LIQUID WASTE CONTAINER WARNING: POTENTIAL BIOHAZARD. INSTRUMENT WASTE COULD BE CONTAMINATED WITH POTENTIALLY INFECTIOUS MATERIALS. OBSERVE BASIC BIOHAZARD PRECAUTIONS. WEAR APPROPRIATE PERSONAL PROTECTIVE EQUIPMENT SUCH AS GLOVES, LAB COATS, AND PROTECTIVE EYEWEAR.

    Description of Event or Problem · 1

    A CUSTOMER AT THE (B)(6) HOSPITAL ((B)(6)) REPORTED THAT A LABORATORY TECHNICIAN WAS SPLASHED IN ONE EYE WHEN DISCONNECTING THE LIQUID WASTE CONTAINER ON THE M2000SP INSTRUMENT. THE WASTE CONTAINER WAS BEING EMPTIED AS PART OF THE INSTRUMENT WEEKLY MAINTENANCE. THE SPLASH OCCURRED AS THE WASTE CONTAINER LID WAS BEING REMOVED. THE TECHNICIAN WAS WEARING A LAB COAT AND GLOVES AT THE TIME OF EXPOSURE. ONE OF THE TECHNICIAN'S GLOVES CAUGHT ON THE CONNECTOR ON TOP OF THE LID. LIQUID WASTE WAS FLICKED UP AS THE LID WAS BEING TUNED AND AS THE GLOVE WAS FREED FROM THE CONNECTOR. THE TECHNICIAN'S EYE WAS IMMEDIATELY RINSED. THE TECHNICIAN WENT TO THE HOSPITAL EMERGENCY ROOM TO RECEIVE MEDICAL ATTENTION. ADDITIONAL INFORMATION AS FOLLOWS WAS PROVIDED: THE TECHNICIAN RECEIVED A HBV VACCINATION FOR PROPHYLAXIS; THE TECHNICIAN'S EYE WAS NOT DAMAGED; THE TECHNICIAN ELECTED TO TAKE 1 DOSE OF HIV POST-EXPOSURE PROPHYLAXIS (PEP); HOWEVER SUBSEQUENTLY OPTED TO NOT CONTINUE WITH THE PEP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT M2000SP JQW ABBOTT MOLECULAR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other