BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2151791 · Received July 6, 2011

    Report

    Report Number
    2531779-2011-04713
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 7, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. ANIMAS WAS ABLE TO PULL A RETAIN SAMPLE HOWEVER CARTRIDGES WITHIN THE LOT ARE EXPIRED THEREFORE FURTHER TESTING WAS NOT PERFORMED. THE PATIENT USED AN EXPIRED CARTRIDGE, WHICH MAY BE A CAUSE OF THE ALLEGED LEAK.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT WHEN SHE TRIED TO ADMINISTER A BOLUS DOSE THROUGH THE PUMP SHE NOTICED AN INSULIN LEAK AT THE LUER CONNECTION BETWEEN THE CARTRIDGE AND INFUSION SET. SHE NOTICED IT WHEN HER BLOOD GLUCOSE LEVELS STARTED TO ELEVATE AND SHE WENT TO CHANGE THE CARTRIDGE. THE PATIENT REPORTS THAT HER BLOOD GLUCOSE LEVEL BECAME "HI" AND SHE BECAME WEAK WITH NAUSEA, VOMITING, AND DRY MOUTH. SHE DID NOT TEST FOR KETONES. AFTER SHE CHANGED OUT HER CARTRIDGE AND TREATED HERSELF WITH AN INJECTION OF INSULIN AND INSULIN FROM THE PUMP HER BLOOD GLUCOSE LEVEL LOWERED TO 385 MG/DL. THE PATIENT IS USING A CARTRIDGE THAT EXPIRED IN (B)(6) 2009.

    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 B201263

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Life Threatening| R