BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2061238 · Received April 11, 2011

    Report

    Report Number
    2531779-2011-02439
    Event Type
    Injury
    Date Received
    April 11, 2011
    Date of Event
    March 10, 2011
    Report Date
    March 11, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE HAS NOT BEEN RETURNED TO ANIMAS. IF THE PRODUCT IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    THE PT REPORTED THAT SHE EXPERIENCED CONSISTENTLY ELEVATED BLOOD GLUCOSE (BG) OF ABOUT 300 MG/DL WITH INTERMITTENT KETONES OVER THE PAST 7 TO 10 DAYS. SHE STATED THAT THIS BG LEVEL IS ATYPICAL FOR HER BUT SAID THAT NO MEDICAL INTERVENTION WAS REQUIRED. THE PT REPORTED THAT SHE HAS USED MORE INSULIN THAN NORMAL AND HAS CHANGED THE CARTRIDGE EVERY TWO DAYS INSTEAD OF TWICE PER WEEK AS USUAL. AT THE SAME TIME AS THE BG EXCURSIONS, SHE BEGAN TO USE CARTRIDGES FROM A NEW SHIPMENT. SHE REPORTED THAT SHE NOTICED THE INSIDE OF THE CARTRIDGE COMPARTMENT WAS DAMP AND SMELLED OF INSULIN WHEN SHE REMOVED A CARTRIDGE TWO DAYS AGO. SHE NOTED THAT HER BG THIS MORNING WAS 45 MG/DL WITH NO SYMPTOMS OF HYPOGLYCEMIA; HER MOST RECENT BG WAS 300 MG/DL WHICH THE PT SAID WAS DUE TO OVER CORRECTION OF THE LOW BG.

    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 B201577

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention