BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2213093 · Received August 16, 2011

    Report

    Report Number
    2531779-2011-05930
    Event Type
    Injury
    Date Received
    August 16, 2011
    Report Date
    July 17, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE WAS NOT RETURNED TO ANIMAS. ALTHOUGH THE CARTRIDGE WAS NOT RETURNED THERE IS NO FURTHER INVESTIGATION NECESSARY WITH RESPECT TO THE LEAK ISSUE. THE PATIENT CLAIMED THAT HE WAS USING CARTRIDGES THAT ANIMAS HAS CONFIRMED TO BE DEFECTIVE. WHEN TESTED, FLUID WAS OBSERVED LEAKING FROM THE PLUNGER END OF THE CARTRIDGE. THIS REPORT IS MADE UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE. CATALOG # = 100-124-01. 2531779-02/25/11-001-R.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY-USER/PATIENT CONTACTED ANIMAS ALLEGING HE HAD MULTIPLE HIGH BLOOD GLUCOSE (BG) EPISODES IN (B)(6) RELATED TO LEAKING CARTRIDGES. THE PATIENT CLAIMED THAT DURING THE TIME OF CONCERN, HE HAD DEVELOPED A BG LEVEL GREATER THAN "400 MG/DL" FOR A WEEK WITH SYMPTOMS OF INCREASED THIRST AND URINATION, IRRITABILITY, AND BLURRED VISION. THE PATIENT WAS UNABLE TO PROVIDE ANY IDENTIFYING INFORMATION REGARDING THE CARTRIDGES THAT HE USED AT THE TIME. HOWEVER, THE PATIENT CLAIMED THAT HE HAD USED CARTRIDGES THAT WERE RELATED TO A RECALL INVOLVING LEAKING CARTRIDGES. DURING THE TIME OF CONCERN, THE PATIENT REPORTEDLY CONTINUED USING THE PUMP, BUT ALSO TOOK INSULIN VIA SYRINGE FOR ADDITIONAL CORRECTIONS. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT HE HAD USED CARTRIDGES RELATED TO A CARTRIDGES LEAK RECALL AND HE DEVELOPED SYMPTOMS THAT SUGGESTIVE OF SEVERE HYPERGLYCEMIA.

    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 44 YR Life Threatening| R