BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLUCOLET 2

    MDR report key: 214110 · Received March 11, 1999

    Report

    Report Number
    MW1015886
    Event Type
    Injury
    Date Received
    March 11, 1999
    Date of Event
    February 26, 1999
    Report Date
    March 3, 1999
    Manufacturer
    BAYER CORP.
    Product Code
    FMK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE NURSING SUPV USED THE PROPER PROCEDURE TO LOAD THE LANCING DEVICE ON THE PLUNGER OF THE GLUCOLET 2. STAFF TRAINS NURSES TO: TWIST THE PROTECTIVE CAP OFF THE LANCET, PUSH THE RELEASE BUTTON, TEST THE PT'S BLOOD AND PLACE THE PLUNGER AND LANCET ON A BEDSIDE TABLE. AN EMPLOYED NURSE PICKED UP THE PLUNGER AND LANCET, AND THE EXPOSED NEEDLE FROM THE LANCET SCRAPED THE PALMAR SURFACE OF HER LEFT HAND AND PUNCTURED HER LEFT INDEX FINGER, DRAWING BLOOD FROM BOTH AREAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLUCOLET 2 GLUCOMETER LANCET FMK BAYER CORP. 5965 *

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention