BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1873089 · Received October 15, 2010

    Report

    Report Number
    2531779-2010-01646
    Event Type
    Injury
    Date Received
    October 15, 2010
    Date of Event
    September 13, 2010
    Report Date
    September 15, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. THE PUMP WAS EVALUATED AND FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERING INSULIN ACCURATELY. INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO ISSUES. NO ALARMS OR PUMP CONDITIONS INDICATING A MALFUNCTION WERE RECORDED IN BLACK BOX OR ALARM HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED BLOOD GLUCOSE OF 400 MG/DL WITH NAUSEA AND VOMITING; THE PATIENT DID NOT HAVE KETONES. HE WAS TREATED IN THE EMERGENCY ROOM WITH IV SALINE FLUIDS; INSULIN WAS GIVEN VIA THE PUMP. A FAMILY MEMBER REPORTED THAT THE PATIENT HAD EXPERIENCED A MINOR ILLNESS ("COLD") AND HAD BLOOD GLUCOSE VALUES OF 300MG/DL TO 400MG/DL DURING THE WEEK LEADING UP TO THE HOSPITAL VISIT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Hospitalization