BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS DIABETES

    MDR report key: 2008567 · Received March 1, 2011

    Report

    Report Number
    MW5019619
    Event Type
    Injury
    Date Received
    March 1, 2011
    Date of Event
    February 13, 2011
    Report Date
    February 23, 2011
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT RECEIVED ANIMAS CARTRIDGE OF A NOW RECALLED LOT# B201583 - THESE CARTRIDGES MAY LEAK CONTENTS LEADING TO INSUFFICIENT DOSE BEING ADMINISTERED. PT HAS USED 10 CARTRIDGES OVER THE LAST 10 - 15 DAYS WITH HIS HUMULIN R U500 INSULIN. PT HAS EXPERIENCED SIGNS OF HYPERGLYCEMIA, BLURRED VISION, HIGH READINGS, VERY TIRED. DOSE, FREQUENCY & ROUTE USED: USE 1 DAILY AS DIRECTED. THERAPY DATE: (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS DIABETES ANIMAS 2ML CARTRIDGE 1'S - 12402 LZG B201583

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other HUMULIN R HI500 CONCENTR 20ML - 500U