BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 2070869 · Received April 15, 2011

    Report

    Report Number
    2531779-2011-02592
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    February 1, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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

    KEYPAD BUTTON PRESSES DO NOT ACTIVATE INTENDED PUMP RESPONSE. THE PT REPORTED THAT THE KEYPAD BUTTONS WERE UNRESPONSIVE WHEN SHE ATTEMPTED TO GIVE A BOLUS. SHE REMOVED THE BATTERY TO REBOOT, AND UPON REBOOTING, THE PUMP DISPLAYED THE VERIFY SCREEN BUT THE PT COULD NOT GET PAST THE VERIFY SCREEN AS THE OK, UP ARROW, AND DOWN ARROW KEYPAD BUTTONS WERE UNRESPONSIVE. THE PT STATED THAT THE UP ARROW HAS BEEN INTERMITTENTLY RESPONSIVE FOR THE PAST SEVERAL WEEKS LEADING UP TO THE INCIDENT. THE PT CONFIRMED THAT THE UP ARROW, DOWN ARROW, AND OK KEYPAD BUTTONS DO NOT SPRING BACK WHEN PRESSED, BUT STATED THAT THE CONTRAST BUTTON IS STILL WORKING PROPERLY. THE PT NOTED THAT SHE WAS CONNECTED TO THE PUMP WHILE IN THE HOT TUB LAST NIGHT, BUT STATED THAT THE PUMP WAS ON THE EDGE OF THE TUB AND WAS NOT SUBMERGED IN THE WATER. SHE CONFIRMED THAT THERE ARE NO SIGNS OF MOISTURE OR CORROSION IN THE BATTERY COMPARTMENT.

    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 18 YR