BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2212521 · Received August 16, 2011

    Report

    Report Number
    2531779-2011-05913
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Report Date
    July 21, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 THE KEYPAD BUTTONS. THE BUTTONS DID NOT HAVE NORMAL SPRING BACK OR CLICK, IT WAS CONFIRMED THAT THE KEYS WERE STICKING WHEN PRESSED AND WHEN THE KEYPAD COVER WAS REMOVED, THERE WAS EVIDENCE OF ADHESIVE/CONTAMINATION FOUND UNDER ALL KEY CONTACTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE KEYPAD BUTTON PRESSES DID NOT ACTIVATE DESIRED PUMP FUNCTIONS. THE REPORTER CLAIMED ALL KEYPAD BUTTONS WERE HARD TO PRESS, STICKING AND REQUIRED MULTIPLE PRESSES FOR A RESPONSE. THERE WAS NO REPORTED PATIENT IMPACT ASSOCIATED WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR