BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1957742 · Received January 4, 2011

    Report

    Report Number
    2531779-2011-00065
    Event Type
    Injury
    Date Received
    January 4, 2011
    Date of Event
    December 8, 2010
    Report Date
    December 8, 2010
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS NOT RETURNED TO ANIMAS. THE PT INCREASED HER BASAL INSULIN DELIVERY RATES, WHICH MAY HAVE CAUSED HER BLOOD GLUCOSE LEVELS TO DECREASE, REQUIRING TREATMENT FROM HER HUSBAND. NO CONCLUSIONS CAN BE MADE FROM PRODUCT INVESTIGATION AND THERE IS NO EVIDENCE OF A PUMP MALFUNCTION.

    Description of Event or Problem · 1

    THE PT CONTACTED ANIMAS TO OBTAIN ASSISTANCE IN CHANGING HER BASAL RATES. SHE STATES SHE INCREASED HER BASAL INSULIN RATES FROM 0.25 UNITS PER HR TO 1.0 UNIT PER HR SETTINGS STARTING AT 12 AM AND 0.5 UNITS PER HR STARTING AT 9 PM W/O FOLLOWING THE PRESCRIPTION OR ADVICE FROM HER DOCTOR. SHE STATES THAT HER BLOOD GLUCOSE LEVEL WAS 19 MG/DL IN THE MORNING. HER HUSBAND REPORTEDLY TREATED HER WITH JUICE AND SUGAR AND THE PT DID NOT SEEK MEDICAL ATTENTION. THE BLOOD GLUCOSE RESULTS WERE REPORTEDLY RESOLVED WITH THE JUICE AND SUGAR GIVEN BY HER HUSBAND.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Life Threatening| R