BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2181736 · Received July 27, 2011

    Report

    Report Number
    2531779-2011-05370
    Event Type
    Injury
    Date Received
    July 27, 2011
    Date of Event
    June 28, 2011
    Report Date
    June 28, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ADDED "LIFE THREATENING."

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP WAS RETURNED FOR AN UNRELATED COMPLAINT AND WAS ADDITIONALLY TESTED FOR POSSIBLE INSULIN DELIVERY ISSUES RELATED TO THIS COMPLAINT. THE TESTING WAS COMPLETED BY PRODUCT ANALYSIS ON (B)(4) 2011. THE CARTRIDGE WAS NOT RETURNED TO ANIMAS; A RETAINED SAMPLE FROM LOT #B201595 WAS TESTED ON (B)(4) 2011. THE PUMP WAS TESTED ON A 29 HOUR FLOW ACCURACY TEST. NO DELIVERY DEFECTS OR MALFUNCTIONS WERE FOUND. ACCORDING TO THE PUMP DELIVERY HISTORY, THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE PROGRAMMED BASAL RATES. NO ALARMS OR PUMP CONDITIONS INDICATING A MALFUNCTION WERE RECORDED IN BLACK BOX OR ALARM HISTORY. THE RETAINED CARTRIDGE SAMPLE PASSED VISUAL INSPECTION WITH NO DAMAGE OR DEFECTS NOTED TO THE LUER CONNECTION OR O-RINGS. A LEAK TEST WAS PERFORMED WITH NO EVIDENT FAILURES; NO LEAKS WERE OBSERVED FROM THE LUER CONNECTION, THE O-RINGS, OR FROM ANY OTHER PART OF THE CARTRIDGE.

    Description of Event or Problem · 1

    A FAMILY MEMBER REPORTED THAT THE PATIENT EXPERIENCED A BLOOD GLUCOSE OF 500 MG/DL WITH KETONES. CUSTOMER SUPPORT (CS) REVIEWED THE PUMP WITH THE FAMILY MEMBER. THE FAMILY MEMBER CONFIRMED THAT ALL OF THE PUMP HISTORY AND SETTINGS WERE CORRECT. SHE REPORTED THAT THERE WAS A SMELL OF INSULIN COMING FROM THE CARTRIDGE COMPARTMENT. SHE CONFIRMED THAT THE CARTRIDGE COMPARTMENT WAS DRY AND SHE COULD NOT FEEL ANY INSULIN. THE FAMILY MEMBER CONFIRMED THAT THE CARTRIDGES WERE CYCLED PRIOR TO BEING FILLED. CS WALKED THE FAMILY MEMBER THROUGH EXAMINING THE CARTRIDGE. THE FAMILY MEMBER CONFIRMED THAT THE CARTRIDGE APPEARED TO BE INTACT BUT STATED THAT THERE WERE AIR BUBBLES IN THE CARTRIDGE. SHE REPORTED THAT THE INSULIN WAS STORED IN THE REFRIGERATOR; CS ADVISED THE FAMILY MEMBER THAT USING REFRIGERATED INSULIN COULD CAUSE AIR BUBBLES AND EXPLAINED HOW TO PREVENT AIR BUBBLES. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA WHILE USING INSULIN PUMP THERAPY.

    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 7 YR Life Threatening| R