BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXENATIDE 2MG/PEN INJ

    MDR report key: 4994461 · Received August 4, 2015

    Report

    Report Number
    MW5055289
    Event Type
    Injury
    Date Received
    August 4, 2015
    Date of Event
    July 22, 2015
    Report Date
    July 28, 2015
    Manufacturer
    ASTRAZENCECA
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    2

    Narratives

    Description of Event or Problem · 1

    PRODUCT DISCHARGED ITSELF INDEPENDENTLY WHEN PROCESS TO PRIME DELIVERY DEVICE FOLLOWED PER PACKAGE INSTRUCTIONS. THIS HAS HAPPENED TWICE WITHIN THE LAST 8 DELIVERY DEVICES (8 WEEKS) FROM THE SAME LOT. PRODUCT IS PRIMED AND MIXED PRIOR TO INFUSION OF MEDICATION. MEDICATION UNABLE TO BE MIXED AND INJECTED INTO PT. SINGLE DELIVERY DEVICE DISPOSED OF EACH TIME. EXENATIDE 2MG/PEN INJ. FREQUENCY: ONCE WEEKLY. ROUTE: SUBCUTANEOUS. DATES OF USE: (B)(6) 2015. REASON FOR USE: HYPERGLYCEMIA AND DIABETES MELLITUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511787 EXENATIDE 2MG/PEN INJ BYDUREON PEN FMI ASTRAZENCECA UNK FC0108
    511788 EXENATIDE 2MG/PEN INJ BYDUREON PEN FMI ASTRAZENCECA UNK FC0108

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention