BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2040037 · Received March 25, 2011

    Report

    Report Number
    2531779-2011-01932
    Event Type
    Malfunction
    Date Received
    March 25, 2011
    Date of Event
    February 23, 2011
    Report Date
    February 23, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Removal / Correction Number
    2531779-02/25/11-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THE CARTRIDGE WAS NOT RETURNED TO ANIMAS. THERE IS NO INVESTIGATION NECESSARY. CARTRIDGES WITH LOT# B201583 WERE CONFIRMED TO BE DEFECTIVE. WHEN TESTED, FLUID WAS OBSERVED LEAKING FROM THE PLUNGER END OF THE CARTRIDGE.

    Description of Event or Problem · 1

    A FAMILY MEMBER REPORTED THAT THE PATIENT EXPERIENCED HIGH BLOOD GLUCOSE LEVELS THAT WERE GREATER THAN 400 MG/DL. SHE STATED THAT THE ISSUE OCCURRED DURING A THREE WEEK PERIOD. THE FAMILY MEMBER SAID THE PATIENT DID NOT TEST POSITIVE FOR KETONES AND SHE DID NOT REPORT SYMPTOMS OF HYPERGLYCEMIA. SHE NOTED THAT AROUND THE SAME TIME SHE NOTICED LEAKAGE OF INSULIN AT THE PLUNGER END OF THE CARTRIDGE. THE FAMILY MEMBER DESCRIBED CORRECT CARTRIDGE USE AND NO ISSUES WITH THE PUMP OR INFUSION SETS WERE DISCOVERED DURING REVIEW OF THE PUMP WITH CUSTOMER SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP CARTRIDGE LZG ANIMAS CORP. IR 1200/1250/2020/OTP B201583

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR