BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTRIDGE, RESERVOIR 2.0 - 2,0- ML

    MDR report key: 1802875 · Received August 10, 2010

    Report

    Report Number
    MW5017073
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    August 5, 2010
    Report Date
    August 10, 2010
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I WENT TO USE MY LAST INSULIN CARTRIDGE FROM ANIMAS CORPORATION AND BEFORE OPENING THE PACKAGE, I NOTICED A BUG OF SOME TYPE IN THE PACKAGE WHICH IS TO BE STERILE. AS THIS WAS MY LAST CARTRIDGE, I COULD NOT USE MY PUMP, AND I WONDER HOW MANY OTHER BUGS I MIGHT HAVE MISSED. BEEN USING THE INSULIN PUMP SINCE APRIL. DATES OF USE: (B)(6) 2010 - (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: DIABETES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARTRIDGE, RESERVOIR 2.0 - 2,0- ML INSULIN CARTRIDGE LZG ANIMAS CORPORATION REF:100-124-02 B201439

    Patients

    Seq Age Sex Outcome Treatment
    1 Other