BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2046779 · Received March 31, 2011

    Report

    Report Number
    2531779-2011-02154
    Event Type
    Injury
    Date Received
    March 31, 2011
    Date of Event
    February 28, 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
    LA, 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 THAT SHE EXPERIENCED BLOOD GLUCOSE (BG) OF 600MG/DL WITH NAUSEA; SHE SAID THAT THE SYMPTOM COULD HAVE BEEN RELATED TO A CONCURRENT ILLNESS. THE PT STATED THAT WHEN SHE REMOVED THE CARTRIDGE HER HAND WAS WET BUT SHE CANNOT CONFIRM THAT THE MOISTURE WAS INSULIN. SHE REPORTED THAT SHE TREATED THE ELEVATED BG VIA THE PUMP AND SHE STATED THAT THE BG EXCURSION RESOLVED AFTER THE CARTRIDGE AND INFUSION SET CHANGE.

    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 B201581

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention