BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2063101 · Received April 12, 2011

    Report

    Report Number
    2531779-2011-02466
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Report Date
    March 15, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVAL. ALL KEYPAD BUTTON PRESSES DID NOT ACTIVATE DESIRED PUMP FUNCTIONS DURING TESTING. IT WAS ALSO FOUND THAT MULTIPLE PRESSES ARE REQUIRED TO ACTIVATE A RESPONSE. DURING INVESTIGATION, THE UP ARROW KEY CONTACT WAS OBSERVED TO BE MISALIGNED. ALL KEYPAD BUTTONS DID NOT HAVE NORMAL SPRING BACK. THERE WAS EVIDENCE OF KEYPAD ADHESIVE FOUND UNDER ALL KEY CONTACTS. UNRELATED TO THE COMPLAINT DURING EVAL, THE DISPLAY WAS FADED UPON START UP, WHICH HAS NO EFFECT ON INSULIN DELIVERY FUNCTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE OK BUTTON REQUIRES SEVERAL PRESSES FOR A RESPONSE. 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