BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2046780 · Received March 31, 2011

    Report

    Report Number
    2531779-2011-02157
    Event Type
    Injury
    Date Received
    March 31, 2011
    Report Date
    March 3, 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
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE WAS NOT RETURNED TO ANIMAS. ALTHOUGH THE CARTRIDGE WAS NOT RETURNED, THERE IS NO FURTHER INVESTIGATION NECESSARY WITH RESPECT TO THE LEAK ISSUE. 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 PT REPORTED ELEVATED BLOOD GLUCOSE (BG) LEVELS DURING A TWO WEEK PERIOD. SHE STATED THAT HER BG WAS ABOUT 200 MG/DL TO 300 MG/DL ONE WEEK; 300 MG/DL TO 400 MG/DL THE NEXT WEEK. SHE REPORTED SOME NAUSEA WITH NO OTHER SYMPTOMS OF HYPERGLYCEMIA; SHE DID NOT CHECK FOR THE PRESENCE OF KETONES. THE PT REPORTED THAT SHE ROTATES INFUSION SITES ON HER ABDOMEN EVERY TWO TO THREE DAYS, SHE DOES NOT USE AREAS THAT ARE SCARRED, AND THE SITES APPEARED NORMAL. SHE REPORTED THAT THREE CARTRIDGES LEAKED NEAR THE PLUNGER END. THE PT NOTED THAT HER BG RESOLVED TO HER NORMAL RANGE AROUND 120 MG/DL WITH EACH INCIDENT AFTER INJECTIONS OF INSULIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMPCARTRIDGE LZG ANIMAS CORP. IR 1200 / 1250 / 2020 / OTP B201581

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention