BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANTUS SOLOSTAR

    MDR report key: 2161219 · Received June 30, 2011

    Report

    Report Number
    2161219
    Event Type
    Malfunction
    Date Received
    June 30, 2011
    Date of Event
    June 28, 2011
    Report Date
    June 30, 2011
    Manufacturer
    BD BECTON DICKINSON
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE RN ATTEMPTED TO ADMINISTER AN INSULIN DOSE WITH THE LANTUS SOLOSTAR PEN, BUT WHEN THE EJECTION BUTTON WAS PRESSED, THE PEN DID NOT INJECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LANTUS SOLOSTAR INSULIN AUTO-INJECTION PEN FMF BD BECTON DICKINSON * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *