BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1844743 · Received September 20, 2010

    Report

    Report Number
    2531779-2010-01302
    Event Type
    Injury
    Date Received
    September 20, 2010
    Date of Event
    August 2, 2010
    Report Date
    August 18, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT REPORTED THAT THERE WAS A CRACK IN THE LUER CONNECTION BETWEEN THE CARTRIDGE AND INFUSION SET. IT IS UNKNOWN IF THE CARTRIDGE OR INFUSION SET IS DAMAGED. THE PATIENT REPORTED DROPPING THE PUMP ON THE LUER CONNECTION PRIOR TO DISCOVERING THE INSULIN LEAK. THE CARTRIDGE IN QUESTION HAS NOT BEEN RETURNED TO ANIMAS. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED ELEVATED BLOOD GLUCOSE LEVELS (>600 MG/DL). THE PATIENT'S MOTHER TREATED HER WITH INSULIN INJECTIONS. THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM; HOWEVER, NO TREATMENT WAS ADMINISTERED, AS THE PATIENT'S BLOOD GLUCOSE WAS NO LONGER ELEVATED, DUE TO INJECTIONS. UPON REMOVAL OF THE PUMP, IT WAS REPORTED THAT INSULIN WAS LEAKING FROM THE LUER CONNECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORP. IR 1200/1250/2020/OTP B201493

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Required Intervention