BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 2033179 · Received February 28, 2011

    Report

    Report Number
    2531779-2011-01210
    Event Type
    Malfunction
    Date Received
    February 28, 2011
    Report Date
    January 30, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO ANIMAS FOR EVAL. IF THE DEVICE IS RETURNED, AN EVAL 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 PUMP REPORTEDLY REBOOTED W/O USER INTERVENTION. THE PT REBOOTED THE PUMP, COMPLETED THE PRIMING STEPS BUT THE PUMP REBOOTED AGAIN. THE PT'S MOM STATED THERE WAS NO DAMAGE TO THE BATTERY CAP AND PUMP. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. A REPLACEMENT PUMP WAS SENT TO THE PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1