BEUDAMED
    FDA Adverse Event Other Summary report: N

    ANIMAS R1000 INFUSION PUMP

    MDR report key: 746537 · Received September 27, 2005

    Report

    Report Number
    MW1036730
    Event Type
    Other
    Date Received
    September 27, 2005
    Report Date
    September 27, 2005
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    AN ANIMAS R1000 INSULIN PUMP PURCHASED JUNE 2003: 1. JUNE 26, 2005: STARTED GIVING OCCLUSION READINGS WHEN PT TRIED GETTING BOLUSES. FOR EXAMPLE, PUMP WOULD GIVE 10 UNITS WHEN 20 UNITS WERE PUNCHED IN, OR GIVE 5 UNITS WHEN 10 UNITS WERE PUNCHED IN. PT STARTED GETTING HIGH BG READINGS, AND PT HAD TO SWITCH TO SYRINGES. PT COULD NOT TELL IF BASAL WAS AFFECTED. ANIMAS SENT A REPLACEMENT PUMP. 2. JULY 7,2005: TWO WEEKS LATER. REPLACEMENT PUMP HAD BUTTONS THAT STUCK, MAKING IT USABLE. ANIMAS SENT OUT A THIRD PUMP. 3. SEPTEMBER 20, 2005: THIRD PUMP STARTED GIVING CONDITIONS READINGS FOR ATTEMPTED BOLUSES, SIMILAR TO JUNE 26,2005 PROBLEMS. PT WOKE UP WITH 390 BG SEPTEMBER 24, 2005 - VERY HIGH FOR PT-AND WAS CONCERNED THAT BASAL ALSO HAD PROBLEMS BUT COULD NOT CONFIRM. 4. SEPTMEBER 27, 2005; FOURTH PUMP WILL BE RECEIVED AS OF THIS DATE. DR'S OFFICE SAYS THAT THIS DEGREE OF FAILURE IS NOT ACCEPTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS R1000 INFUSION PUMP INSULIN PUMP LZG ANIMAS CORPORATION R1000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Other