BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2060734 · Received April 8, 2011

    Report

    Report Number
    2531779-2011-02361
    Event Type
    Malfunction
    Date Received
    April 8, 2011
    Date of Event
    March 5, 2011
    Report Date
    March 8, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE WAS RETURNED TO ANIMAS. ALTHOUGH, THE CARTRIDGE WAS 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 HAD ELEVATED BLOOD GLUCOSE SINCE MARCH 4. SHE STATES HER READINGS HAVE BEEN BETWEEN 400 AND 500 MG/DL AND HAS EXPERIENCED NAUSEA AND VOMITING ON MARCH 5. SHE SAID THAT AT 6 AM, THE MORNING SHE CALLED ANIMAS, HER BLOOD GLUCOSE LEVEL WAS 597 MG/DL. SHE DENIED ANY CHEST PAIN, SHORTNESS OF BREATH, NAUSEA OR VOMITING AND SAID SHE WAS EXHAUSTED. WHEN SHE CHANGED OUT HER CARTRIDGE AND INFUSION SET AND HER BLOOD GLUCOSE DECREASED TO 432 MG/DL. WHEN SHE CHANGED OUT HER CARTRIDGE SHE NOTICED THAT INSULIN LEAKED FROM THE CARTRIDGE. SHE SAYS THAT SHE ALSO RECEIVES OCCLUSION ALARMS WHEN USING HER BOX OF CARTRIDGES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Life Threatening