BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 2070522 · Received March 29, 2011

    Report

    Report Number
    2531779-2011-02037
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Date of Event
    February 1, 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
    NC, 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. THE OK AND UP ARROW KEYPAD BUTTONS WERE INTERMITTENTLY RESPONSIVE DURING TESTING. THE BUTTONS SPRING BACK WHEN PRESSED, BUT REQUIRE MULTIPLE PRESSES TO OBTAIN A RESPONSE. DURING INVESTIGATION, THE UP ARROW KEY CONTACT WAS OBSERVED TO BE MISALIGNED. INVESTIGATION CONFIRMED THAT THE OK KEYPAD BUTTON SYMBOL IS WORN. THERE WAS EVIDENCE OF KEYPAD ADHESIVE 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 OK KEYPAD BUTTONS HAVE BEEN SLOW TO RESPOND OVER THE PAST FEW WEEKS. SHE NOTED THAT THE OK BUTTON SYMBOL IS WORN, AND THAT THE BUTTONS DO NOT CLICK AS EXPECTED WHEN PRESSED. THE PT CONFIRMED THAT THE RUBBER KEYPAD IS INTACT; DENIED EXPOSING THE PUMP TO MOISTURE; AND STATED THAT SHE WEARS THE PUMP IN HER 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 52 YR