BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1171101 · Received September 22, 2008

    Report

    Report Number
    2531779-2008-00609
    Event Type
    Injury
    Date Received
    September 22, 2008
    Date of Event
    September 14, 2008
    Report Date
    September 14, 2008
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    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 SPECS AT THE TIME OF RELEASE. EXCESS INSULIN WAS ADMINISTERED TO THE PT 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. THE PT HAS CONTINUED TO USE THE PUMP WITH NO REPORTED SUBSEQUENT EVENTS.

    Description of Event or Problem · 1

    THE PT RECEIVED EMERGENCY ROOM TREATMENT AFTER EXCESS INSULIN WAS ADMINISTERED 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 CORP. ANIMAS 2020

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization