BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1033845 · Received April 24, 2008

    Report

    Report Number
    2531779-2008-00227
    Event Type
    Injury
    Date Received
    April 24, 2008
    Date of Event
    March 10, 2008
    Report Date
    March 24, 2008
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. EVALUATION REVEALED A DAMAGED DISPLAY SCREEN CONSISTENT WITH THE PATIENT'S REPORT BUT DEMONSTRATED THAT PUMP INSULIN DELIVERY WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERY ACCURACY. THIS REPORT IS MADE UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE.

    Description of Event or Problem · 1

    THE PATIENT WAS HOSPITALIZED FOR ELEVATED BLOOD GLUCOSE LEVELS. THE PATIENT REPORTED THAT HER PHYSICIAN ATTRIBUTED THE BLOOD GLUCOSE ELEVATIONS TO STEROID USE. THE PATIENT ALSO REPORTED THAT THE PUMP DISPLAY SCREEN WAS DAMAGED SUBSEQUENT TO THE HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION IR 1250

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization