BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1874164 · Received October 15, 2010

    Report

    Report Number
    2531779-2010-01652
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    September 16, 2010
    Report Date
    September 16, 2010
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO ANIMAS. EVAL HAS NOT YET BEEN COMPLETED. WHEN EVAL IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    THE PT REPORTED THAT THE SELECTION HIGHLIGHT ON THE PUMP DISPLAY WAS SCROLLING WITHOUT USER INTERVENTION. THE PT TRIED TO TAKE A CORRECTION BOLUS FOR A BLOOD GLUCOSE LEVEL OF 204 MG/DL, BUT COULD NOT PROGRAM THE CORRECT AMOUNT BECAUSE THE SELECTION AMOUNT ON THE DISPLAY KEPT INCREASING. THE PT SAID SHE WAS ABLE TO STOP DELIVERY OF THE PROGRAMMED 7.0 UNITS AFTER ABOUT 2.3 UNITES WERE DELIVERED BY PRESSING A BUTTON. THE PT DISCONNECTED THE INFUSION SET FROM HER BODY AND WENT ON A BACKUP INSULIN PLAN WITH INJECTIONS. THE PT SAYS SHE DOES NOT EXPOSE THE PUMP TO WATER. SHE DID NOT DETECT ANY VISIBLE KEYPAD DAMAGE AND SAYS THE BUTTONS FEEL NORMAL. THE PT'S BLOOD GLUCOSE READING WHEN SHE CALLED ANIMAS WAS REPORTEDLY 156 MG/DL.

    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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR