BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 2033752 · Received March 23, 2011

    Report

    Report Number
    2531779-2011-01842
    Event Type
    Malfunction
    Date Received
    March 23, 2011
    Date of Event
    January 23, 2011
    Report Date
    February 23, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. ALL KEYPAD BUTTONS REQUIRED EXCESSIVE FORCE TO OBTAIN A RESPONSE DURING TESTING. DURING INVESTIGATION, THE UP ARROW AND CONTRAST BUTTON KEY CONTACTS WERE OBSERVED TO BE MISALIGNED. ALL BUTTON KEY CONTACTS WERE FOUND TO INTERMITTENTLY SPRING BACK WHEN PRESSED. THERE WAS EVIDENCE OF KEYPAD ADHESIVE FOUND UNDER ALL KEY CONTACTS. UNRELATED TO THE KEYPAD COMPLAINT, A DISCOLORED DISPLAY SCREEN WAS FOUND ON INVESTIGATION.

    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 AND DOWN ARROW KEYPAD BUTTONS HAVE BEEN STICKING FOR THE PAST MONTH. SHE STATED THAT THE CONTRAST BUTTON BECAME UNRESPONSIVE A MONTH AGO, AND THE UP AND DOWN ARROW KEYPAD BUTTONS BEGAN INTERMITTENTLY RESPONDING AT THE SAME TIME. THE FAMILY MEMBER DENIED PHYSICAL DAMAGE TO THE RUBBER KEYPAD; DENIED EXPOSING THE PUMP TO WATER; AND STATED THAT THE PT WEARS THE PUMP CLIPPED TO HIS WAIST.

    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