BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1032839 · Received April 22, 2008

    Report

    Report Number
    2531779-2008-00223
    Event Type
    Injury
    Date Received
    April 22, 2008
    Date of Event
    March 22, 2008
    Report Date
    March 22, 2008
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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 PATIENT'S FATHER REPORTED, THAT THE PATIENT INADVERTENTLY 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 PERFORMING A PRIME. ADDITIONALLY, THE PUMP NOTIFIES THE USER TO DISCONNECT FROM THE INFUSION SET THREE TIMES DURING THE REWIND/PRIME SEQUENCE. THE PATIENT HAS CONTINUED TO USE THE PUMP WITH NO REPORTED SUBSEQUENT EVENTS. THIS REPORT IS MADE UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE.

    Description of Event or Problem · 1

    THE PATIENT RECEIVED EMERGENCY ROOM TREATMENT FOR HYPOGLYCEMIA. THE PATIENT INADVERTENTLY ADMINISTERED EXCESS INSULIN BY 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 CORPORATION ANIMAS 2020

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention