BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 742705 · Received July 21, 2005

    Report

    Report Number
    2531779-2005-00075
    Event Type
    Malfunction
    Date Received
    July 21, 2005
    Date of Event
    June 24, 2005
    Report Date
    June 24, 2005
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    Removal / Correction Number
    Z-0211-05
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS EVENT. THIS SOFTWARE ERROR WAS IDENTIFIED BY ANIMAS CORPORATION AND A RECALL WAS INITIATED IN SEPTEMBER 2004. REFER TO RECALL #Z-0211-05.

    Description of Event or Problem · 1

    PUMP DOES NOT PROVIDE REMINDER WHEN IN SUSPEND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORP. IR 1200 *

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR