BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2220979 · Received August 23, 2011

    Report

    Report Number
    2531779-2011-06149
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Report Date
    July 26, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. THE PUMP WAS RETURNED TO ANIMAS. THE RESULTS OF THE INVESTIGATION WERE AS NOTED: THE KEYPAD APPEARED INTACT WITH NO LIFTING OR PEELING OBSERVED; HOWEVER, TESTING CONFIRMED INTERMITTENT RESPONSES TO BUTTON PRESSES ON ALL KEYPAD BUTTONS. MULTIPLE BUTTON PRESSES WERE REQUIRED BEFORE THE BUTTONS WOULD ENGAGE. THE BUTTONS DID NOT HAVE NORMAL SPRING BACK OR CLICK AND THERE WAS EVIDENCE OF ADHESIVE/CONTAMINATION FOUND UNDER ALL KEY CONTACTS WHEN THE KEYPAD WAS REMOVED. IT WAS ALSO OBSERVED THAT THE BUTTON CONTACTS ON THE UP, DOWN AND OK BUTTONS WERE MISALIGNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE KEYPAD BUTTON PRESSES DID NOT ACTIVATE DESIRED PUMP FUNCTIONS. THE PATIENT REPORTED THAT ALL THE KEYPAD BUTTONS WERE EITHER STICKING AND/OR UNRESPONSIVE WHEN PRESSED. THERE WAS NO REPORTED PATIENT IMPACT ASSOCIATED WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM 2020 INSULIN INFUSION PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR