BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2031818 · Received March 21, 2011

    Report

    Report Number
    2531779-2011-01785
    Event Type
    Malfunction
    Date Received
    March 21, 2011
    Report Date
    February 21, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    UNKNOWN

    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. THE DOWN KEYPAD BUTTON WAS FOUND TO BE HYPERSENSITIVE WHEN PRESSED. DURING INVESTIGATION, THE DOWN ARROW KEY CONTACT WAS OBSERVED TO BE MISALIGNED. THERE WAS EVIDENCE OF KEYPAD ADHESIVE FOUND UNDER THE DOWN ARROW BUTTON.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DOWN ARROW BUTTON IS VERY SENSITIVE AND IS INTERMITTENTLY RESPONDING. IT WAS ALSO REPORTED THERE ARE NO TEARS OR PEELING OF THE KEYPAD.

    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