BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1221926 · Received November 4, 2008

    Report

    Report Number
    2531779-2008-00753
    Event Type
    Injury
    Date Received
    November 4, 2008
    Date of Event
    October 3, 2008
    Report Date
    October 4, 2008
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. EVALUATION DEMONSTRATED THAT THE PUMP WAS FUNCTIONING WITHIN REQUIRED DELIVERY ACCURACY. THE PUMP WAS FOUND TO HAVE A COSMETIC SCRATCH ON THE DISPLAY LENS, WHICH IS UNRELATED TO THE COMPLAINT.

    Description of Event or Problem · 1

    PATIENT'S MOTHER REPORTS HOSPITALIZATION DUE TO DKA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANIMAS 2020

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization