BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1241591 · Received November 20, 2008

    Report

    Report Number
    2531779-2008-00822
    Event Type
    Injury
    Date Received
    November 20, 2008
    Date of Event
    September 19, 2008
    Report Date
    October 27, 2008
    Manufacturer
    ANIMAS CORP.
    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 VISIBLY SCRATCHED 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

    PATIENT'S MOTHER REPORTS HOSPITALIZATION DUE TO ELEVATED BLOOD GLUCOSE LEVELS AND DKA.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Hospitalization