BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1210240 · Received October 22, 2008

    Report

    Report Number
    2531779-2008-00712
    Event Type
    Injury
    Date Received
    October 22, 2008
    Date of Event
    September 18, 2008
    Report Date
    September 21, 2008
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVAL. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. THE PT INADVERTENTLY ADMINISTERED EXCESS INSULIN BY LOADING THE CARTRIDGE INTO THE PUMP WHILE ATTACHED TO THE INFUSION SET. THE USER GUIDE INSTRUCTS THE PT TO DISCONNECT FROM THE INFUSION SET PRIOR TO INITIATING THE PRIME/REWIND SEQUENCE. THE PT HAS CONTINUED TO USE THE PUMP WITH NO REPORTED SUBSEQUENT EVENTS.

    Description of Event or Problem · 1

    PT REPORTS HE RECEIVED EMS TREATMENT DUE TO INADVERTENT INSULIN INFUSION WHICH OCCURRED WHILE MANIPULATING THE CARTRIDGE WHILE ATTACHED TO THE INFUSION SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORP. IR1200

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention