BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1210155 · Received October 22, 2008

    Report

    Report Number
    2531779-2008-00713
    Event Type
    Injury
    Date Received
    October 22, 2008
    Date of Event
    September 21, 2008
    Report Date
    September 21, 2008
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. EVALUATION DEMONSTRATED THE PUMP WAS FUNCTIONING WITHIN REQUIRED SPECIFICATIONS AND DELIVERY ACCURACY. THE PT ADMINISTERED EXCESS INSULIN BY PRIMING THE PUMP WHILE ATTACHED TO THE INFUSION SET. THE PUMP USER GUIDE INSTRUCTS USERS TO DISCONNECT FROM THE INFUSION SET PRIOR TO PRIMING IT. ADDITIONALLY, THE PUMP NOTIFIES THE USER TO DISCONNECT FROM THE INFUSION SET THREE TIMES DURING THE REWIND/PRIME SEQUENCE.

    Description of Event or Problem · 1

    PATIENT REPORTS ER TREATMENT DUE TO AN INADVERTENT INSULIN INFUSION AS SHE WAS PRIMING THE PUMP 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. ANIMAS 2020

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention