BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 2080155 · Received April 6, 2011

    Report

    Report Number
    2531779-2011-02321
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    January 27, 2011
    Report Date
    March 10, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 CONFIRMED THAT THE AUDIO BOLUS BUTTON COVER IS MISSING. 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 TICKING AND INTERMITTENTLY UNRESPONSIVE. A FAMILY MEMBER REPORTED THAT THE CONTRAST AND DOWN ARROW KEYPAD BUTTONS HAVE BEEN STICKING AND REQUIRE MULTIPLE HARD PRESSES TO OBTAIN A RESPONSE FOR THE PAST 6 WEEKS. SHE ALSO REPORTED THAT THE AUDIO BOLUS BUTTON COVER FELL OFF TODAY. THE FAMILY MEMBER DENIED PHYSICAL DAMAGE TO THE RUBBER KEYPAD; DENIED EXPOSING THE PUMP TO WATER AND CLEANING PRODUCTS; AND STATED THAT THE PT 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 15 YR