BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 2070834 · Received April 15, 2011

    Report

    Report Number
    2531779-2011-02653
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Report Date
    March 20, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PATIENT'S FATHER CONTACTED ANIMAS ALLEGING THE PATIENT'S PUMP WAS FROZEN AT THE VERIFY SCREEN WAS CONTINUOUSLY BEEPING. AT THE TIME OF THE ISSUE, THE REPORTER CONFIRMED THE O-RING WAS VISIBLE. ONCE THE BATTERY CAP WAS TIGHTENED AND O-RING NO LONGER VISIBLE, THE PATIENT'S FATHER REPORTED THAT THE SCREEN WENT BLACK. THE REPORTER REPLACED THE BATTERY WITH A NEW BATTERY, AND STATED THE PUMP'S SCREEN REMAINED BLANK AND THERE WERE NO AUDIO SOUNDS COMING FROM THE PUMP. AT THE TIME OF TROUBLESHOOTING, THE PATIENT DENIED ANY VISIBLE PROBLEMS WITH THE BATTERY CAP. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT.

    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