BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2421264 · Received January 19, 2012

    Report

    Report Number
    2531779-2012-00455
    Event Type
    Injury
    Date Received
    January 19, 2012
    Date of Event
    December 20, 2011
    Report Date
    December 20, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE 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.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE CARTRIDGE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: A RESERVED SAMPLE FROM THE SAME LOT NUMBER #B201737 WAS TESTED. A VISUAL INSPECTION OF THE CARTRIDGE WAS PERFORMED. NO DAMAGE OR DEFECTS WERE NOTED. A LEAK TEST WAS PERFORMED WITH NO FAILURES OBSERVED OR FLUID OBSERVED LEAKING OUT AT THE PLUNGER END OF THE CARTRIDGE. A FILL TEST WAS COMPLETED WITH NO AIR BUBBLES FOUND INSIDE THE CARTRIDGE. EACH CARTRIDGE LOT IS SUBJECTED TO A STATISTICAL SAMPLING PLAN AND MUST PASS TESTING FOR FORCE (OCCLUSION AND LOSS OF PRIME), CRACKS, AND FOREIGN MATERIAL PRIOR TO RELEASE FOR DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2011 THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM (ER) FOR ELEVATED BLOOD GLUCOSE (BG) LEVELS. THE PATIENT STATED THAT HE EXPERIENCED BG BETWEEN 400 - 500 MG/DL AND FELT SICK SINCE THE AFTERNOON OF (B)(6) 2011 AFTER CHANGING OUT THE SITE/SET. THE PATIENT REPORTEDLY DID NOT CHECK FOR KETONES. HE STATED THAT HIS BG HAD NOT RESPONDED TO A CORRECTION BOLUS PRIOR TO GOING TO THE ER. THE PATIENT REPORTEDLY REMAINED ON THE PUMP AND WAS TREATED WITH AN IV INSULIN DRIP IN THE ER; THE PATIENT'S BG REPORTEDLY DECREASED TO 298 MG/DL. TROUBLESHOOTING INDICATED THAT THE PATIENT HAD USED REFRIGERATED INSULIN TO FILL THE CARTRIDGE THE MORNING OF (B)(6) 2011, AND AIR BUBBLES WERE FOUND IN THE TUBING AND CARTRIDGE. THE PATIENT STATED THAT THERE WAS NO LEAKAGE, REDNESS, OR BLOOD BUT THAT THERE WERE AREAS OF HARDNESS, LUMPS AND SCAR TISSUE AT THE INSERTION SITES. TROUBLESHOOTING INDICATED THAT PUMP HISTORIES AND SETTINGS WERE CORRECT AND THAT THE PUMP WAS DELIVERING INSULIN ACCURATELY. CUSTOMER SUPPORT (CS) REVIEWED RECOMMENDATIONS FOR CHANGING THE SITE/SET WHEN BGS ARE ELEVATED AND INSTRUCTED THE PATIENT ON REMOVING AIR BUBBLES FROM THE CARTRIDGE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED HYPERGLYCEMIA WHILE USING INSULIN PUMP THERAPY. USE ERROR LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT, AS THE PATIENT WAS FILLING THE CARTRIDGE WITH REFRIGERATED INSULIN, LEADING TO AIR BUBBLES IN THE SYSTEM WHICH CAN LEAD TO UNDER-DELIVERY OF INSULIN.

    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 47 YR Required Intervention