BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 2041546 · Received March 10, 2011

    Report

    Report Number
    2531779-2011-01495
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    January 23, 2011
    Report Date
    February 13, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 REQUIRED EXCESSIVE FORCE TO OBTAIN A RESPONSE DURING TESTING. DURING INVESTIGATION, THE UP ARROW, DOWN ARROW, AND OK BUTTON KEY CONTACTS WERE OBSERVED TO BE MISALIGNED. ALL KEYPAD KEY CONTACTS INTERMITTENTLY SPRING BACK WHEN PRESSED. 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. A FAMILY MEMBER REPORTED THAT THE OK KEYPAD BUTTON HAS BEEN SLOW TO RESPOND OVER THE LAST 3 WEEKS, AND NOW REQUIRES EXCESSIVE FORCE AND MULTIPLE BUTTON PRESSES TO OBTAIN A RESPONSE. SHE NOTED THAT ALL OTHER BUTTONS ARE RESPONDING AS EXPECTED. THE FAMILY MEMBER REPORTED THAT THE KEYPAD BUTTONS CLICK AND SPRING BACK AS EXPECTED. SHE DENIED PHYSICAL DAMAGE TO THE RUBBER KEYPAD; DENIED THAT THE PUMP HAS BEEN EXPOSED TO WATER OR CLEANING PRODUCTS; AND STATED THAT THE PT WEARS THE PUMP IN A POUCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONE TOUCH PING

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR