BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1000212 · Received February 19, 2008

    Report

    Report Number
    2531779-2008-00115
    Event Type
    Injury
    Date Received
    February 19, 2008
    Date of Event
    January 27, 2008
    Report Date
    January 27, 2008
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    NA
    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 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 PT STATED HE MAY HAVE 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 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. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    THE PT RECEIVED EMS TREATMENT FOR HYPOGLYCEMIA AND INEBRIATION. THE PT STATED THAT HE MAY HAVE 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 CORP. ANIMAS 2020

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention