BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1983190 · Received February 2, 2011

    Report

    Report Number
    2531779-2011-00581
    Event Type
    Malfunction
    Date Received
    February 2, 2011
    Report Date
    January 3, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILLED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE PATIENT, ALONG WITH HER PARENTS, CONTACTED ANIMAS ALLEGING THAT SHE WAS IN THE MIDDLE OF DELIVERING A BOLUS AND IT WAS CANCELLED WITHOUT HER PRESSING ANY BUTTONS. ACCORDING TO THE PUMP'S BOLUS HISTORY, 0.90 UNITS OF 6.90 UNITS WERE DELIVERED AND IT WAS NOTED TO BE CANCELLED. THE PT REPORTEDLY WAS ABLE TO DELIVER THE REMAINING AMOUNT OF INSULIN WITH NO CANCELLATIONS. THE KEYPAD REPORTEDLY IS INTACT AND THE BUTTONS ALL FEEL NORMAL AND BOUNCE/SPRING BACK. THERE WAS NO REPORTED PATIENT IMPACT ASSOCIATED WITH THIS COMPLAINT. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE DELIVERY OF A BOLUS REPORTEDLY WAS CANCELLED WITH NO USER INTERVENTION. A REPLACEMENT PUMP WAS SENT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORP. ONE TOUCH PING

    Patients

    Seq Age Sex Outcome Treatment
    1