BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 2033780 · Received March 23, 2011

    Report

    Report Number
    2531779-2011-01856
    Event Type
    Malfunction
    Date Received
    March 23, 2011
    Date of Event
    January 1, 2010
    Report Date
    February 24, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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

    IT WAS REPORTED THAT THE KEYPAD BUTTONS WERE STICKING. THE PT REPORTED THAT THE CONTRAST, DOWN ARROW, AND OK KEYPAD BUTTONS HAVE BEEN INTERMITTENTLY STICKING FOR THE PAST FEW MONTHS. SHE NOTED THAT THE BUTTONS DO NOT ALWAYS CLICK AS EXPECTED. THE PT STATED THAT THE OK KEYPAD BUTTON BECAME STUCK WHILE SHE WAS PRIMING LAST NIGHT AND THE PUMP PRIMED 11 UNITS OF INSULIN WHILE SHE WAS DISCONNECTED FROM THE PUMP. SHE NOTED THAT THE BUTTON SYMBOL IS WORN OFF OF THE OK BUTTON AND IT FEELS THIN, BUT STATED THERE IS NO OTHER PHYSICAL DAMAGE TO THE RUBBER KEYPAD. THE PT REPORTED THAT THE PUMP HAS PREVIOUSLY BEEN EXPOSED TO POOL AND LAKE WATER, AND HAD ACCIDENTALLY BEEN DROPPED IN A HOT TUB ON ONE OR TWO OCCASIONS. SHE SATED THAT SHE WEARS THE PUMP ON HER WAIST WITH A CLIP, IN HER BRA, OR ON HER LEG WITH A THIGH STRAP.

    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 39 YR