BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 3252944 · Received July 29, 2013

    Report

    Report Number
    2531779-2013-12033
    Event Type
    Injury
    Date Received
    July 29, 2013
    Report Date
    July 22, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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) 2013 REPORTING THAT THE INFUSION SET TUBING CAME LOOSE FROM THE CARTRIDGE AT THE LUER LOCK CONNECTION. THE REPORTER INDICATED THAT THE LUER LOCK WAS TIGHTENED APPROPRIATELY BUT THE TUBING WAS COMING LOOSE AT NIGHT AND SOMETIMES DURING THE DAY. THE REPORTER STATED THAT ONE OCCASION RESULTED IN BLOOD GLUCOSE LEVELS UP TO 21 MMOL/L; THE REPORTER INDICATED GOING TO A HEALTH CARE PROFESSIONAL AND BEING TREATED VIA INSULIN INJECTION AND FLUIDS FOR DIABETIC KETOACIDOSIS. THE REPORTER CONFIRMED THAT THERE WAS NO VISIBLE ISSUE WITH THE TUBING OR CARTRIDGE CONNECTIONS. THIS REPORT IS MADE BASED ON THE ALLEGATION OF REQUIRED MEDICAL INTERVENTION FOR DIABETIC KETOACIDOSIS ASSOCIATED WITH AN ALLEGED LUER LOCK CONNECTION ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352147 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Life Threatening| R