BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 562597 · Received September 26, 2004

    Report

    Report Number
    2531779-2004-00059
    Event Type
    Injury
    Date Received
    September 26, 2004
    Date of Event
    June 28, 2004
    Report Date
    June 28, 2004
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PT ADMITTED TO HOSP TWO TIMES WITH DKA WITH DKA WHILE WEARING THE IR1200. PT HAD BEEN HOSPITALIZED PRIOR TO STARTING PUMP AND EXPERIENCED DKA AFTER GOING OFF PUMP. FIRST DKA WITH PUMP WAS 27 DAYS EARLER. REVIEWED PUMP HISTORY WHICH SHOWED PUMP PLACED IN SUSPEND MODE WITH NO BOLUS OR BASAL. RESUME DATE JAN, 2000. UNABLE TO DETERMINE HOW LONG PUMP IN SUSPEND. ALARM HISTORY SHOWS DATE JAN 2000. CONCLUDED THAT THEY WERE UNABLE TO DETERMINE IF PUMP WAS MALFUNCTIONING OR IF PT WAS MANIPULATING THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORP. IR1200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Hospitalization