BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2042032 · Received March 24, 2011

    Report

    Report Number
    2531779-2011-01934
    Event Type
    Injury
    Date Received
    March 24, 2011
    Date of Event
    February 24, 2011
    Report Date
    February 24, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Removal / Correction Number
    2531779-02/25/11/001-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE INVOLVED WITH THIS COMPLAINT HAS NOT BEEN RETURNED TO ANIMAS FOR INVESTIGATION. THERE IS NO INVESTIGATION NECESSARY. CARTRIDGES WITH LOT #B201581 WERE CONFIRMED TO BE DEFECTIVE. WHEN TESTED, FLUID WAS OBSERVED LEAKING FROM THE PLUNGER END OF THE CARTRIDGE.

    Description of Event or Problem · 1

    THE PATIENT REPORTEDLY HAD INSULIN LEAKING FROM HIS CARTRIDGE AND ALLEGEDLY DEVELOPED ELEVATED BLOOD GLUCOSE LEVELS WITH SYMPTOMS OF BLURRED VISION. THE PATIENT DENIED SEEING BUBBLES IN THE TUBING OR CARTRIDGE AT THE TIME OF THE REPORTED INCIDENT. THE PATIENT ADMINISTERED SELF-TREATMENT WITH AN INSULIN INJECTION AND DID NOT SEEK ADDITIONAL MEDICAL INTERVENTION. THE PATIENT CHANGED THE INSULIN CARTRIDGE AND HIS BLOOD GLUCOSE LEVELS ARE BACK TO THE "NORMAL" (80-120 MG/DL RANGE). THIS COMPLAINT IS BEING REPORTED BECAUSE THERE WAS INSULIN LEAKING FROM THE INSULIN CARTRIDGE AND THE PATIENT ALLEGEDLY DEVELOPED ELEVATED HIGH BLOOD GLUCOSE LEVELS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Life Threatening| R