BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 2070530 · Received March 29, 2011

    Report

    Report Number
    2531779-2011-02022
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Date of Event
    January 28, 2011
    Report Date
    February 28, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT 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

    IT WAS REPORTED THAT THE KEYPAD BUTTONS WERE STICKING AND INTERMITTENTLY UNRESPONSIVE. THE PT REPORTED THAT THE KEYPAD HAS BEEN SLOW TO RESPOND OVER THE PAST MONTH, AND YESTERDAY, THE UP ARROW AND THE OK BUTTON STARTED STICKING INTERMITTENTLY. SHE NOTED THAT THE BUTTONS REQUIRE EXCESSIVE FORCE AND MULTIPLE PRESSES TO OBTAIN A RESPONSE. THE PT STATED THAT THE BUTTONS STILL CLICK AND SPRING BACK AS EXPECTED. SHE STATED THAT THE PUMP IS EXPOSED TO WATER OCCASIONALLY; DENIED PHYSICAL DAMAGE TO THE RUBBER KEYPAD; DENIED EXPOSING THE PUMP TO CLEANING PRODUCTS; AND STATED THAT SHE WEARS THE PUMP IN VARIOUS PLACES WITH A CLIP.

    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 19 YR