BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2032268 · Received March 23, 2011

    Report

    Report Number
    2531779-2011-01877
    Event Type
    Injury
    Date Received
    March 23, 2011
    Date of Event
    February 20, 2011
    Report Date
    February 20, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    01/2010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE WAS RETURNED TO ANIMAS. A VISUAL INSPECTION OF THE CARTRIDGE WAS PERFORMED. NO DAMAGE OR DEFECTS WERE NOTED. A LEAK TEST WAS PERFORMED WITH NO FAILURES. THERE IS NO LEAKS OBSERVED FROM THE LUER CONNECTION, PLUNGER, O-RINGS, OR ANYWHERE ELSE IN THE CARTRIDGE.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PATIENT'S MOTHER/REPORTER CLAIMED THAT THE PATIENT EXPERIENCED A BLOOD GLUCOSE READING OF "400 MG/DL" WITH SYMPTOM OF "VERY THIRSTY" WHILE EXPERIENCING SOME ISSUE WITH THE INSULIN CARTRIDGE LEAK. THE REPORTER GAVE A BOLUS VIA SYRINGE TO CORRECTION THE ELEVATED READING. THERE WERE NO REPORTED KETONES AT THE TIME OF CONCERN. REPORTEDLY, THE PATIENT WAS OUT AND ABOUT WHEN SHE GOT AN ALARM WHICH SUSPENDED THE INSULIN PUMP. ATTEMPTS TO REWIND, LOAD, AND PRIME THE INSULIN PUMP WERE UNSUCCESSFUL. WHEN SHE GOT, THE REPORTER WAS ABLE TO RESUME THE FUNCTIONALITY OF THE INSULIN PUMP AFTER A SUCCESSFUL REWIND, LOAD, AND PRIME OF THE INSULIN PUMP. THE REPORTER SAW NO CRACKS IN THE CARTRIDGE AND CLAIMED THAT THE INSULIN MAY HAVE BEEN LEAKING FROM THE BOTTOM OF THE PLUNGER INTO THE PUMP. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTER CLAIMED THAT THE PATIENT HAD ELEVATED READINGS WITH SYMPTOMS THAT CAN BE SUGGESTIVE OF HYPERGLYCEMIA WHILE EXPERIENCING THE ALLEGED LEAKING INSULIN CARTRIDGE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP CARTRIDGE LZG ANIMAS CORP. IR 1200/1250/2020/OTP B201614

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Life Threatening