BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2028271 · Received March 17, 2011

    Report

    Report Number
    2531779-2011-01703
    Event Type
    Injury
    Date Received
    March 17, 2011
    Date of Event
    February 19, 2011
    Report Date
    February 19, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVAL. THE RESULTS OF THE INVESTIGATION WERE AS NOTED: CARTRIDGE LOT# B201852 WAS CONFIRMED TO BE DEFECTIVE AND FOUND TO BE LEAKING FROM THE PLUNGER SIDE OF THE CARTRIDGE PAST THE FIRST O-RING AND OUT THE HOLE IN BETWEEN THE TWO O-RINGS.

    Description of Event or Problem · 1

    IN (B)(6), 2011, THE PT'S MOM/REPORTER CONTACTED ANIMAS CLAIMING THAT HER CHILD HAD BLOOD GLUCOSE READINGS OF OVER "400 MG/DL" WITH KETONES FOR THE PAST TEN DAYS WHILE USING CARTRIDGE WITH LOT# 201582 WHICH REPORTEDLY WAS LINKING. DURING TROUBLESHOOTING, THE CUSTOMER CARE ADVOCATE NOTED THAT A POOL OF INSULIN IN THE PLUNGER, WHERE PLUNGER MEETS BARREL OF CARTRIDGE. THE CARTRIDGE COMPARTMENT WAS DAMP WITH INSULIN AND A STRONG ODOR OF INSULIN PERMEATED THE AIR. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTER CLAIMED THAT THE PT WAS HYPERGLYCEMIC FOR TEN DAYS WHILE USING THE ALLEGED INSULIN CART WITH LOT# 201582.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP CARTRIDGE LZG ANIMAS CORPORATION IR 1200/ 1250/ 2020/ OTP B201582

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Life Threatening