BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 2041608 · Received March 10, 2011

    Report

    Report Number
    2531779-2011-01471
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    January 1, 2011
    Report Date
    February 9, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 AND REQUIRED EXCESSIVE FORCE TO OBTAIN A RESPONSE DURING TESTING. ALL BUTTON KEY CONTACTS DID NOT ALWAYS SPRING BACK AS EXPECTED WITH BUTTON PRESSES. THERE WAS NO EVIDENCE OF KEYPAD ADHESIVE FOUND UNDER ALL BUTTON 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 OK AND DOWN ARROW KEYPAD BUTTONS HAVE BEEN INTERMITTENTLY UNRESPONSIVE FOR THE PAST SEVERAL WEEKS. SHE NOTED THAT THE OK AND DOWN ARROW BUTTONS INTERMITTENTLY DO NOT CLICK AND SPRING BACK AS EXPECTED. SHE DENIED ANY PHYSICAL DAMAGE TO THE RUBBER KEYPAD; DENIED THAT THE PUMP HAS BEEN EXPOSED TO MOISTURE; AND STATED THAT THE PT 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 16 YR