BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2070525 · Received March 29, 2011

    Report

    Report Number
    2531779-2011-02014
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Report Date
    February 28, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    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 UP ARROW, DOWN ARROW AND OK KEYPAD BUTTONS WERE INTERMITTENTLY RESPONSIVE DURING TESTING. IT WAS ALSO FOUND THAT THE CONTRAST KEYPAD BUTTON REQUIRED EXCESSIVE FORCE TO ACTIVATE A RESPONSE DURING TESTING. DURING INVESTIGATION, THE DOWN ARROW KEY CONTACT WAS OBSERVED TO BE MISALIGNED. THE CONTRAST KEYPAD BUTTON DID NOT ALWAYS SPRING BACK WHEN PRESSED. IT WAS FOUND THAT THE UP ARROW, DOWN ARROW AND OK KEYPAD BUTTONS INTERMITTENTLY SPRING BACK WHEN PRESSED. THERE WAS EVIDENCE OF KEYPAD ADHESIVE FOUND UNDER ALL KEY CONTACTS. UNRELATED TO THE COMPLAINT, DURING EVAL, IT WAS OBSERVED THAT THE PUMP DISPLAYED A DIM REDDISH VERIFY SCREEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DOWN ARROW IS NOT RESPONDING AS WELL AS IT USED TO AND THE OK BUTTON REQUIRES ADD'L PRESSES WITH MORE FORCE. IT WAS REPORTED THAT THE KEYPAD IS INTACT AND THE PUMP IS NOT EXPOSED TO WATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORP. ANIMAS 2020 NA

    Patients

    Seq Age Sex Outcome Treatment
    1