BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1070917 · Received July 7, 2008

    Report

    Report Number
    2531779-2008-00378
    Event Type
    Injury
    Date Received
    July 7, 2008
    Date of Event
    June 9, 2008
    Report Date
    June 9, 2008
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVAL. EVAL REVEALED A VISIBLE BATTERY COMPARTMENT CRACK AND A BLANK DISPLAY SCREEN, BUT DEMONSTRATED THAT PUMP INSULIN DELIVERY WAS OPERATING WITHIN REQUIRED SPECS AND DELIVERY ACCURACY.

    Description of Event or Problem · 1

    THE PT WAS HOSPITALIZED FOR ELEVATED BLOOD GLUCOSE LEVELS. THE PT'S HUSBAND ALSO REPORTED THAT THE PUMP EXHIBITED A DAMAGED DISPLAY SCREEN.

    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 Hospitalization