BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2056100 · Received April 1, 2011

    Report

    Report Number
    2531779-2011-01944
    Event Type
    Injury
    Date Received
    April 1, 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
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE WAS NOT RETURNED TO ANIMAS. THERE IS NO INVESTIGATION NECESSARY. CARTRIDGES WITH LOT# B201582 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 PT REPORTEDLY NOTICED ABOUT 2-3 MONTHS AGO THAT SHE COULD SMELL INSULIN IN THE CARTRIDGE COMPARTMENT BUT DID NOT SEE ANY INSULIN OR FEEL ANY WETNESS. SHE CLAIMED THAT HER BLOOD GLUCOSE LEVELS HAVE BEEN RUNNING 400-500 MG/DL FOR THE LAST 3-4 DAYS WITH SYMPTOMS OF NAUSEA, SHORTNESS OF BREATH, AND CHEST PAIN. THE PT ATTRIBUTES HER HIGH BLOOD GLUCOSE LEVELS AND SYMPTOMS TO HER BRONCHITIS AND GASTROPARESIS. THE PT IS ALSO TAKING ANTI-INFLAMMATORY AND STEROID MEDICATIONS. WHEN THE PT INSPECTED HER CARTRIDGE ON (B)(6) 2011, THE PT NOTICED THERE WAS INSULIN LEAKING IN THE CARTRIDGE COMPARTMENT. THE PT WAS ADVISED TO DISCONTINUE USING HER CARTRIDGES WITH LOT# B201582. THE PT'S CURRENT HEALTH CONDITION (BRONCHITIS) AND CURRENT MEDICATIONS CAN CONTRIBUTE TO ELEVATED BLOOD GLUCOSE LEVELS; HOWEVER, THIS COMPLAINT IS STILL BEING REPORTED BECAUSE THE PT ALLEGEDLY DEVELOPED ELEVATED BLOOD GLUCOSE LEVELS WITH SYMPTOMS WHEN USING CARTRIDGES THAT HAD A LEAKING INSULIN ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP CARTRIDGE LZG ANIMAS CORP. IR1200/1250/2020/OTP B201582

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R