BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1930610 · Received December 1, 2010

    Report

    Report Number
    2531779-2010-02631
    Event Type
    Malfunction
    Date Received
    December 1, 2010
    Date of Event
    October 31, 2010
    Report Date
    November 1, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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

    IT WAS REPORTED THAT THE PUMP LOCKED ITSELF MULTIPLE TIMES WITHOUT USER INTERVENTION. A FAMILY MEMBER STATED THAT THE PATIENT CAN UNLOCK THE PUMP ONLY BY REMOVING THE BATTERY. THE FAMILY MEMBER DENIED THAT THE BUTTONS COULD HAVE BEEN PRESSED BY MISTAKE. THE PUMP ALLEGEDLY LOCKED AT DIFFERENT TIMES OF THE DAY AND THE PATIENT WAS ENGAGED IN DIFFERENT ACTIVITIES PRIOR TO EACH EVENT. ONE TIME, DURING A ROUTINE PRIME STEP, THE SCREEN STARTED FLASHING AND THE PUMP LOCKED WITHOUT USER INTERVENTION. THIS TIME THE PATIENT WAS ABLE TO EASILY UNLOCK THE PUMP. THE PATIENT DENIED ANY SIGNS OF KEYPAD PEELING, STICKING, OR OTHER DAMAGE. SHE CONFIRMED THAT THE BUTTONS FEEL NORMAL, THEY CLICK AND SPRING BACK AS USUAL, AND SHE DOES NOT PRESS SEVERAL TIMES OR HARDER TO ACHIEVE A RESPONSE. THE PATIENT DENIED EXPOSING THE PUMP TO WATER OR CLEANING THE PUMP WITH ANY TYPE OF SOLVENT. THE FAMILY MEMBER STATED THAT THE PATIENT WILL CONTINUE TO USE THE PUMP AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORP. IR1250 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR