BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 2080159 · Received April 6, 2011

    Report

    Report Number
    2531779-2011-02330
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    March 10, 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
    KY, 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. IT WAS CONFIRMED THAT THE KEYPAD BUTTONS ARE STICKING WHEN PRESSED. DURING INVESTIGATION, THE OK AND DOWN ARROW KEY CONTACTS WERE OBSERVED TO BE INVERTED, AND THE UP ARROW KEY CONTACT WAS MISALIGNED. 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 INTERMITTENTLY UNRESPONSIVE. A FAMILY MEMBER REPORTED THAT THE UP ARROW, DOWN ARROW, AND OK KEYPAD BUTTONS HAVE BECOME INCREASINGLY UNRESPONSIVE TO BUTTON PRESSES. SHE NOTED THAT THE BUTTONS STICK, AND THEY DO NOT CLICK AND SPRING BACK WHEN PRESSED. THE FAMILY MEMBER DENIED PHYSICAL DAMAGE TO THE RUBBER KEYPAD; DENIED EXPOSING THE PUMP TO WATER; AND STATED THAT THE PT CARRIES THE PUMP IN HER BRA, ON HER WAIST WITH A CLIP, OR 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 18 YR