BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2072964 · Received April 13, 2011

    Report

    Report Number
    2531779-2011-02749
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    December 26, 2010
    Report Date
    March 26, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. IT WAS OBSERVED THAT THE KEYPAD BUTTON SYMBOLS ARE WORN. EVAL CONFIRMED THAT THE KEYPAD BUTTONS ARE INTERMITTENTLY RESPONSIVE. THERE WAS EVIDENCE OF KEYPAD ADHESIVE FOUND UNDER ALL BUTTON KEY CONTACTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE KEYPAD BUTTONS WERE INTERMITTENTLY UNRESPONSIVE. A FAMILY MEMBER REPORTED THAT THE UP ARROW AND DOWN ARROW KEYPAD BUTTONS HAVE BEEN INTERMITTENTLY UNRESPONSIVE FOR THE PAST 3 MONTHS. SHE NOTED THAT THE OK, UP ARROW, AND DOWN ARROW BUTTON SYMBOLS ARE WORN, AND THAT THE BUTTONS STILL CLICK AND SPRING BACK WHEN PRESSED. THE FAMILY MEMBER CONFIRMED THAT THE KEYPAD IS INTACT; DENIED EXPOSING THE PUMP TO WATER; AND STATED THAT THE PT WEARS THE PUMP ON HER WAIST WITH A CLIP.

    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