BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1231603 · Received November 13, 2008

    Report

    Report Number
    2531779-2008-00798
    Event Type
    Injury
    Date Received
    November 13, 2008
    Date of Event
    October 13, 2008
    Report Date
    October 18, 2008
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. EVALUATION REVEALED A COSMETIC SCRATCH ON THE DISPLAY LENS, WHICH IS UNRELATED TO THE COMPLAINT. THE INSULIN DELIVERY WAS FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS FOR DELIVERY ACCURACY.

    Description of Event or Problem · 1

    PT REPORTS HOSPITALIZATION DUE TO ELEVATED BLOOD GLUCOSE LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION IR1250

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization