BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1153267 · Received September 8, 2008

    Report

    Report Number
    2531779-2008-00541
    Event Type
    Injury
    Date Received
    September 8, 2008
    Date of Event
    July 29, 2008
    Report Date
    July 29, 2008
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. EVALUATION REVEALED A TEAR IN THE KEYPAD COVER BUT DEMONSTRATED THAT PUMP INSULIN DELIVERY WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERY ACCURACY.

    Description of Event or Problem · 1

    THE PATIENT WAS HOSPITALIZED FOR ELEVATED BLOOD GLUCOSE LEVELS. THE PATIENT'S HUSBAND ALSO REPORTED THAT THE PUMP KEYPAD COVER WAS DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORP. IR 1200

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention