BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 2091238 · Received April 20, 2011

    Report

    Report Number
    2531779-2011-02712
    Event Type
    Malfunction
    Date Received
    April 20, 2011
    Date of Event
    March 23, 2011
    Report Date
    March 23, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. THE KEYPAD WAS FOUND TO BE INTACT; NO PEELING OR LIFTING WAS OBSERVED. THE CONTRAST, UP ARROW, AND OK KEYPAD BUTTONS WERE INTERMITTENTLY RESPONSIVE, AND THE DOWN ARROW BUTTONS WAS UNRESPONSIVE DURING TESTING. IT WAS OBSERVED THAT ALL BUTTONS SPRING BACK WHEN PRESSED EXCEPT THE DOWN ARROW BUTTON. DURING INVESTIGATION, THE DOWN ARROW KEY CONTACT WAS OBSERVED TO BE INVERTED. 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 STICKING AND UNRESPONSIVE. A FAMILY MEMBER REPORTED THAT THE UP ARROW AND DOWN ARROW KEYPAD BUTTONS ARE STICKING AND ARE NOT RESPONDING TO PRESSES. SHE NOTED THAT THE BUTTONS DO NOT CLICK WHEN PRESSED. THE FAMILY MEMBER CONFIRMED THAT THE KEYPAD IS INTACT; AND DENIED EXPOSING THE PUMP TO WATER AND CLEANING PRODUCTS.

    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 74 YR