BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 2070531 · Received March 29, 2011

    Report

    Report Number
    2531779-2011-02024
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 1, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVAL. THE KEYPAD WAS FOUND TO BE INTACT; NO PEELING OR LIFTING WAS OBSERVED. ALL KEYPAD BUTTONS WERE INTERMITTENTLY RESPONSIVE DURING TESTING. INVESTIGATION REVEALED THAT ALL KEYPAD BUTTONS SPRING BACK AS EXPECTED WHEN PRESSED, BUT REQUIRE MULTIPLE PRESSES TO OBTAIN A RESPONSE. THERE WAS EVIDENCE OF KEYPAD CONTAMINATION FOUND UNDER ALL KEY CONTACTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE KEYPAD BUTTONS WERE INTERMITTENTLY UNRESPONSIVE. THE PT REPORTED THAT THE UP ARROW AND DOWN ARROW KEYPAD BUTTONS ARE SLOW TO RESPOND. HE NOTED THAT THE BUTTONS SPRING BACK AS EXPECTED WHEN PRESSED. THE PT DENIED EXPOSING THE PUMP TO MOISTURE, AND STATED THAT HE WEARS THE PUMP IN HIS POCKET.

    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 31 YR