BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2032316 · Received March 23, 2011

    Report

    Report Number
    2531779-2011-01861
    Event Type
    Injury
    Date Received
    March 23, 2011
    Date of Event
    February 11, 2011
    Report Date
    February 22, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Removal / Correction Number
    2531779-02/25/11-001-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE WAS NOT RETURNED TO ANIMAS. 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 REPORTER REPORTED THAT ON (B)(6), 2011, THE PT OBTAINED A BLOOD GLUCOSE READING OF 'GREATER THAN 200 MG/DL'. ON THAT DAY, THE PT NOTED THE INSULIN CARTRIDGE WAS LEAKING INTO THE PUMP'S CARTRIDGE COMPARTMENT. THE PT REPLACED THE CARTRIDGE AND HIS ELEVATED BLOOD GLUCOSE LEVELS RESOLVED. ON (B)(6), 2011, THE PT EXPERIENCED THE SYMPTOMS OF NAUSEA, VOMITING AND CHEST PAIN. THE PT WAS ADMITTED TO THE HOSPITAL FOR 24 HOURS OBSERVATION. TROUBLESHOOTING REVEALED THE PT'S TECHNIQUE WAS CORRECT, THERE WERE NO ISSUES WITH THE INFUSION SITE, THE TUBING AND CANNULA WERE CORRECT AND THE TOTAL DAILY DELIVERY AND PROGRAMMED WERE CORRECT AND MATCHED.

    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 B201581

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Hospitalization| L| R