BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2760588 · Received September 26, 2012

    Report

    Report Number
    2531779-2012-11269
    Event Type
    Malfunction
    Date Received
    September 26, 2012
    Report Date
    September 28, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMITTED: (B)(4) 2012 DEVICE EVALUATION: THE INSULIN PUMP HAS BEEN RETURNED AND WAS EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: ON INVESTIGATION, UNRELATED TO THE ORIGINAL COMPLAINT, THE KEYPAD WAS FOUND TO BE FULLY INTACT WITHOUT PEELING OR VISIBLE DAMAGE. THE CONTRAST BUTTON WAS NOTED TO HAVE INTERMITTENT UNRESPONSIVENESS. THE KEYPAD COVER WAS REMOVED FOR INVESTIGATION AND REVEALED CONTAMINATION UNDER THE CONTACT OF THE CONTRAST BUTTON. ADDITIONALLY, THE THREADS IN THE BATTERY COMPARTMENT WERE NOTED TO BE STRIPPED.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON AND ALLEGED THAT THEY CANNOT GET THE BATTERY CAP OFF THE PUMP. THE REPORTER STATED THAT BATTERY CAP WAS REPLACED MORE THAN 6 MONTHS. THE REPORTER DENIED DAMAGE OR MOISTURE TO THE PUMP. THE PUMP IS REPORTEDLY CLEANED WITH AN ALCOHOL SWAB. THE USER'S GUIDE INSTRUCTS THE USER NOT TO USE ALCOHOL TO CLEAN THE PUMP. THE PUMP IS KEPT IN A POCKET. THERE WAS NO REPORTED ADVERSE EVENT 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 11 YR