BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2002531 · Received February 16, 2011

    Report

    Report Number
    2531779-2011-00530
    Event Type
    Injury
    Date Received
    February 16, 2011
    Date of Event
    December 29, 2010
    Report Date
    December 31, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP AND CARTRIDGE ARE NOT BEING RETURNED TO ANIMAS FOR EVALUATION.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PATIENT CONTACTED ANIMAS REPORTING THAT HE WAS HOSPITALIZED ON (B)(6) 2010, FOR DKA. THE PATIENT INDICATED THAT HE WAS TAKEN OFF THE PUMP AND PLACED ON AN INSULIN DRIP. UPON ADMISSION, THE PATIENT'S BLOOD GLUCOSE (BG) LEVEL WAS OVER "400 MG/DL" AND HE WAS VOMITING. HE WAS DISCHARGED ON (B)(6) 2010. THE PATIENT CLAIMED THAT THE CAUSE OF THE ADMISSION WAS THAT HE HAD NOT TIGHTENED THE CARTRIDGE TO THE TUBING CORRECTLY. THEREFORE, INSULIN WAS REPORTEDLY LEAKING OUT AT THE CONNECTION. THE PATIENT STATED THAT THERE WAS NO DEFECT IN THE SUPPLIES. THE PATIENT ADMITTED THAT HE WAS NOT PAYING ATTENTION WHEN TIGHTENING THE CONNECTION. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE REPORTER CLAIMED THAT THE PATIENT WAS HOSPITALIZED FOR DKA.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Hospitalization| L| R