BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2233231 · Received September 2, 2011

    Report

    Report Number
    2531779-2011-06448
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Report Date
    August 4, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. THE RESULTS OF THE INVESTIGATION WERE AS NOTED: THE ISSUE WITH THE KEYPAD BUTTON MALFUNCTION WAS CONFIRMED THROUGH PRODUCT ANALYSIS. THE KEYPAD BUTTONS ARE INTERMITTENTLY RESPONDING TO USER INPUTS DURING TESTING. THERE WAS EVIDENCE OF KEYPAD ADHESIVE FOUND UNDER THE KEY CONTACTS. UNRELATED TO THE ISSUE, THE DISPLAY IS REDDISH AND THERE IS A CRACKED BATTERY CASE. 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. (B)(6).

    Description of Event or Problem · 1

    THIS COMPLAINT IS BEING REPORTED AS A MALFUNCTION DUE TO THE ALLEGED KEYPAD ISSUE. REPORTEDLY, THE UP AND DOWN ARROWS REQUIRE MULTIPLE PRESSES TO ENGAGE A RESPONSE. THERE WAS NO EVIDENCE OF PRODUCT MISUSE. THE PUMP IS BEING RETURNED FOR INVESTIGATION. THERE WAS NO REPORT OF 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 21 YR