BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2861680 · Received December 7, 2012

    Report

    Report Number
    2531779-2012-14292
    Event Type
    Injury
    Date Received
    December 7, 2012
    Report Date
    November 11, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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 INDICATING THAT THE PATIENT'S BLOOD GLUCOSE LEVEL HAS BEEN ELEVATED TO 400-500MG/DL OVER THE WEEKEND. THE PATIENT HAS REPORTEDLY BEEN EXPERIENCING AIR BUBBLES IN THE CARTRIDGE AND TUBING. THE PATIENT'S CARTRIDGE FILLING TECHNIQUE WAS REVIEWED AND WAS FOUND TO BE INCORRECT. THE PATIENT REPORTEDLY WAS NOT CYCLING THE CARTRIDGE PRIOR TO FILLING AND WAS NOT REMOVING BUBBLES CORRECTLY PRIOR TO INSERTION OF THE CARTRIDGE IN THE PUMP. THIS REPORT IS BEING MADE BASED ON THE INDICATION THAT THE PATIENT EXPERIENCED ELEVATED BLOOD GLUCOSE LEVELS RELATED TO USE ERROR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Life Threatening