BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1050256 · Received May 22, 2008

    Report

    Report Number
    2531779-2008-00271
    Event Type
    Injury
    Date Received
    May 22, 2008
    Date of Event
    April 18, 2008
    Report Date
    April 18, 2008
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. EVALUATION REVEALED COSMETIC SCRATCHES ON THE DISPLAY LENS. LOSS OF PRIME WARNINGS CONSISTENT WITH THE PT'S REPORT WERE OBSERVED IN THE HISTORY BUT COULD NOT BE DUPLICATED, PUMP INSULIN DELIVERY WAS FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERY ACCURACY.

    Description of Event or Problem · 1

    THE PT EXPERIENCED HYPOGLYCEMIA AND GLUCAGON WAS ADMINISTERED. THE PT'S FATHER REPORTED THAT THE PUMP EMITTED LOSS OF PRIME WARNINGS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention