BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1911887 · Received November 24, 2010

    Report

    Report Number
    2531779-2010-02545
    Event Type
    Malfunction
    Date Received
    November 24, 2010
    Date of Event
    October 26, 2010
    Report Date
    October 26, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    A FAMILY MEMBER REPORTED THAT THE PT EXPERIENCED BLOOD GLUCOSE ELEVATIONS (125MG/DL TO 316MG/DL) WITHOUT SYMPTOMS OF HYPERGLYCEMIA FOR ONE TO TWO DAYS. THE FAMILY MEMBER REPORTED THAT SHE CHANGED THE INFUSION SET YESTERDAY AND CANNOT CONFIRM THE TIME OF DAY. SHE STATED THAT SHE DID NOT EXAMINE THE SET THAT SHE REMOVED TO CHECK THE CONDITION OF THE CANNULA. THE FAMILY MEMBER DENIED PROBLEMS WITH SITES, THAT IS, THERE WAS NO REDNESS, IRRITATION OR SCAR TISSUE. SHE REPORTED NO DIFFICULTIES WITH INFUSION SET INSERTIONS INTO THE USUAL LEG SITES. THE FAMILY MEMBER DENIED LEAKAGE OR SMELL OF INSULIN AT CURRENT SITE AND DENIED AIR BUBBLES IN THE TUBING OR CARTRIDGE. SHE NOTED THAT THE PT'S BLOOD GLUCOSE RESPONDED TO MANUAL INJECTION OF THE SAME INSULIN AS SHE USED IN THE PUMP. THE FAMILY MEMBER ASSERTED THAT THE TIME AND DATE ARE APPROPRIATELY PROGRAMMED, THE BASAL INSULIN IS SET TO THE CORRECT RATE AND HAS BEEN ACCURATELY DELIVERED, BOLUS APPEARED TO HAVE BEEN FULLY AND ACCURATELY DELIVERED, THE ADVANCED BOLUS SETTINGS ARE CORRECT, AND THERE ARE NO RELEVANT ALARMS IN THE HISTORY. IN SPRITE OF HER INABILITY TO DISCOVER ANY MALFUNCTION OR DEFECT, THE FAMILY MEMBER CONTINUED TO ALLEGE THAT "THE PUMP WAS NOT WORKING."

    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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR