BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2091242 · Received April 20, 2011

    Report

    Report Number
    2531779-2011-02715
    Event Type
    Malfunction
    Date Received
    April 20, 2011
    Date of Event
    March 24, 2011
    Report Date
    March 24, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. THE KEYPAD WAS FOUND TO BE INTACT; NO PEELING OR LIFTING WAS OBSERVED. IT WAS OBSERVED THAT THE OK BUTTON SYMBOL IS WORN. THE OK KEYPAD BUTTON WAS INTERMITTENTLY RESPONSIVE DURING TESTING. THERE WAS EVIDENCE OF KEYPAD CONTAMINATION FOUND UNDER THE OK KEY CONTACT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE KEYPAD BUTTONS WERE INTERMITTENTLY UNRESPONSIVE. THE PT STATED THAT THE OK BUTTON IS UNRESPONSIVE TO INITIAL PRESSES. SHE NOTED THAT THE KEYPAD BUTTONS FEEL NORMAL AND CLICK WHEN PRESSED, BUT THE OK BUTTON STAYS IN THE DOWN POSITION SOMETIMES AFTER BEING PRESSED. THE PT CONFIRMED THAT THE KEYPAD IS INTACT; DENIED EXPOSING THE PUMP TO WATER; AND STATED THAT SHE WEARS THE PUMP IN HER BRA AND THE PUMP IS EXPOSED TO PERSPIRATION.

    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 58 YR