BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2080146 · Received April 6, 2011

    Report

    Report Number
    2531779-2011-02327
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    March 3, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVAL. THE KEYPAD WAS FOUND TO BE INTACT; NO PEELING OR LIFTING WAS OBSERVED. THE DOWN ARROW KEYPAD BUTTON WAS INTERMITTENTLY RESPONSIVE DURING TESTING. DURING INVESTIGATION, THE DOWN ARROW KEY CONTACT WAS OBSERVED TO BE INVERTED AND MISALIGNED. THE UP ARROW KEY CONTACT WAS FOUND TO BE MISALIGNED. EVAL CONFIRMED THAT THE BUTTON SYMBOLS ARE WORN. THERE WAS EVIDENCE OF KEYPAD CONTAMINATION FOUND UNDER ALL KEY CONTACTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE KEYPAD BUTTONS WERE STICKING AND INTERMITTENTLY UNRESPONSIVE. A FAMILY MEMBER REPORTED THAT THE DOWN ARROW KEYPAD BUTTON HAS BEEN INTERMITTENTLY UNRESPONSIVE FOR THE PAST WEEK. SHE NOTED THAT THE DOWN ARROW BUTTON DOES NOT CLICK AND SPRING BACK, AND IS STICKING IN THE DOWN POSITION. THE FAMILY MEMBER CONFIRMED THAT THE RUBBER KEYPAD IS INTACT, BUT NOTED THAT THE BUTTON SYMBOLS ARE WORN. SHE STATED THAT THE PT WEARS THE PUMP IN A POUCH 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 11 YR