BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 2041598 · Received March 10, 2011

    Report

    Report Number
    2531779-2011-01506
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    February 6, 2011
    Report Date
    February 13, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVAL 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 DOWN ARROW KEYPAD BUTTON WAS SLOW TO RESPOND LAST WEEK, AND NOW REQUIRES EXCESSIVE FORCE AND MULTIPLE PRESSES TO OBTAIN A RESPONSE. SHE NOTED THAT WHEN THE DOWN ARROW BUTTON DOES RESPOND, IT IS OVERLY RESPONSIVE AND KEEPS SCROLLING. THE PT REPORTED THAT ALL OTHER KEYPAD BUTTONS ARE RESPONDING AS EXPECTED. SHE STATED THAT THE BUTTONS CLICK AND SPRING BACK AS EXPECTED. THE PT DENIED PHYSICAL DAMGE TO THE RUBBER KEYPAD; DENIED THAT THE PUMP HAS BEEN EXPOSED TO WATER OR CLEANING PRODUCTS; AND STATED THAT SHE WEARS THE PUMP IN VARIOUS PLACES WITH A CLIP OR CASE.

    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 59 YR