BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2853188 · Received November 30, 2012

    Report

    Report Number
    2531779-2012-14115
    Event Type
    Injury
    Date Received
    November 30, 2012
    Report Date
    November 2, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE HAS NOT BEEN RETURNED TO ANIMAS. IF THE DEVICE 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 REPORTER CONTACTED ANIMAS ON (B)(6) 2012, REPORTING BLOOD GLUCOSE LEVELS ELEVATED BETWEEN 500 MG/DL AND HI ON THE METER (OVER 600 MG/DL). TROUBLESHOOTING OF THE INCIDENT NOTED THAT THERE WAS AIR IN THE TUBING. THE REPORTER INDICATED THAT USUALLY THERE WAS NO AIR IN THE CARTRIDGE. THE CARTRIDGE FILLING TECHNIQUE WAS REVIEWED AND FOUND THAT THE REPORTER MAY NOT HAVE BEEN TIGHTENING THE NEEDLE APPROPRIATELY DURING FILLING. THE REPORTER ALSO INDICATED BEING UNSURE IF THE TUBING WAS TIGHTENED ENOUGH TO THE CARTRIDGE. CUSTOMER SUPPORT ADVISED THE PATIENT ON TIGHTENING THE NEEDLE AND THE TUBING TO PREVENT AIR IN THE SYSTEM AND TO TRY TO ALLOW THE CARTRIDGE TO SIT FOR 30 MINUTES PRIOR TO PLACING IN THE CARTRIDGE TO ALLOW THE CARTRIDGE TO DEBUBBLE. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA RELATED TO POTENTIAL ISSUES WITH THE CARTRIDGE FILLING TECHNIQUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM IR1200/1250/2020/OTP CART

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Life Threatening