BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2060722 · Received April 8, 2011

    Report

    Report Number
    2531779-2011-02409
    Event Type
    Malfunction
    Date Received
    April 8, 2011
    Date of Event
    January 27, 2011
    Report Date
    March 10, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVAL HAS NOT YET BEEN COMPLETED. WHEN EVAL IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE KEYPAD BUTTONS WERE STICKING AND INTERMITTENTLY UNRESPONSIVE. THE PT REPORTED THAT THE DOWN ARROW KEYPAD BUTTON HAS BEEN STICKING, AND THE PUMP WILL FREQUENTLY REMAIN LOCKED DESPITE BUTTON PRESSES FOR THE PAST 6 WEEKS. SHE NOTED THAT THE DOWN ARROW BUTTON DOES NOT CLICK AND SPRING BACK WHEN PRESSED, AND STICKS IN THE DOWN POSITION. THE PT CONFIRMED THAT THE RUBBER KEYPAD IS INTACT, AND STATED THAT SHE WEARS THE PUMP IN HER BRA OR ON HER WAIST.

    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 42 YR