BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2992174 · Received March 7, 2013

    Report

    Report Number
    2531779-2013-02454
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    February 13, 2013
    Report Date
    February 13, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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

    ON (B)(6) 2013 THE REPORTER CONTACTED ANIMAS ALLEGING THAT THE PATIENT HAS BEEN EXPERIENCING ELEVATED BLOOD GLUCOSE (BG) RELATED TO AIR BUBBLES IN THE CARTRIDGE AND THE INFUSION SET TUBING. THE REPORTER NOTED THAT THE PATIENT HAD ISSUES WITH AIR BUBBLES OVER THE LAST SIX MONTHS OR SO. THE REPORTER STATED THAT ON (B)(6) 2013 THE PATIENT'S BG RANGED FROM 143 MG/DL TO 327 MG/DL WITH SMALL KETONES. THE REPORTER STATED THAT THE SITE WAS CHANGED ON (B)(6) 2013 PRIOR TO BEDTIME AND THE PATIENT'S BG THEN DECREASED TO 96 MG/DL. THE PATIENT'S FASTING BG THE MORNING OF (B)(6) 2013 WAS REPORTEDLY 117 MG/DL, AND THEN AT 10 AM, WAS UP TO 583 MG/DL. THE REPORTER NOTED SMALL KETONES AND A SLIGHT INCREASE IN THIRST WITH ELEVATED BGS. THE REPORTER DENIED ANY OTHER SIGNS OR SYMPTOMS OF HYPERGLYCEMIA. THE REPORTER STATED THAT THE BG OF 583 MG/DL WITH TREATED WITH A CORRECTION INJECTION, AND 45 MINUTES AFTER THE INJECTION THE PATIENT'S BG WAS 383 MG/DL. THE REPORTER CONFIRMED THAT THE INSULIN BEING USED IS AT ROOM TEMPERATURE. THE REPORTER STATED THAT SHE IS ABLE TO CLEAR THE AIR BUBBLES IN THE SYSTEM WHEN THEY ARE NOTICED, BUT THEN THEY APPEAR AGAIN. TROUBLESHOOTING INDICATED THAT THE CARTRIDGES ARE CYCLED TWO TO THREE TIMES AND THE SITE AND SET ARE CHANGED EVERY TWO TO THREE DAYS. CUSTOMER TECHNICAL SUPPORT (CTS) ADVISED THE REPORTER TO CYCLE CARTRIDGES ONE TO TWO TIMES INSTEAD OF TWO TO THREE. CTS ALSO ADVISED THE REPORTER TO BE SURE THE PLUNGER IS KEPT STRAIGHT WHILE CYCLING. CTS ALSO ADVISED THE REPORTER ON HOW TO APPROPRIATELY TIGHTEN THE NEEDLE TO THE CARTRIDGE PRIOR TO FILLING. CTS REVIEWED SOME DE-BUBBLING TECHNIQUES WITH THE REPORTER AND ADVISED THE REPORTER TO CALL BACK IF THE AIR BUBBLE ISSUE CONTINUES AFTER CHANGING TECHNIQUE. THERE WAS NO CARTRIDGE DEFECT IDENTIFIED DURING TROUBLESHOOTING. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY EXPERIENCED HYPERGLYCEMIA WHILE USING INSULIN PUMP THERAPY WITH USE ERROR OF THE CARTRIDGE AS A CAUSE OR CONTRIBUTOR IN THE ALLEGED BG EXCURSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97450 ANIMAS INSULIN CARTRIDGE INSULIN PUMP CARTRIDGE LZG ANIMAS CORPORATION ANM IR1200/1250/2020/OTP CART

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Life Threatening