BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 2072707 · Received March 31, 2011

    Report

    Report Number
    2531779-2011-02119
    Event Type
    Malfunction
    Date Received
    March 31, 2011
    Date of Event
    February 16, 2011
    Report Date
    March 2, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 UP ARROW AND DOWN ARROW KEYPAD BUTTONS WERE INTERMITTENTLY RESPONSIVE DURING TESTING. THE OK AND CONTRAST KEYPAD BUTTONS REQUIRED EXCESSIVE FORCE TO ACTIVATE DURING TESTING. DURING INVESTIGATION, ALL KEY CONTACTS WERE OBSERVED TO BE MISALIGNED. IT WAS OBSERVED THAT ALL KEY CONTACTS INTERMITTENTLY SPRING BACK WHEN PRESSED. THERE WAS EVIDENCE OF KEYPAD ADHESIVE FOUND UNDER ALL KEY CONTACTS.

    Description of Event or Problem · 1

    KEYPAD BUTTON PRESSES DO NOT ACTIVATE INTENDED PUMP RESPONSE. THE PATIENT REPORTED THAT THE DOWN ARROW BUTTON BEGAN STICKING TWO WEEKS AGO. SHE NOTED THAT THE DOWN ARROW BUTTON WOULD GET STUCK WHEN PROGRAMMING A TEMPORARY BASAL PROGRAM, AND THAT MULTIPLE PRESSES ARE REQUIRED TO OBTAIN A RESPONSE. THE PATIENT STATED THAT THE DOWN ARROW BUTTON DOES NOT CLICK AND FEELS ABNORMAL. SHE REPORTED THAT ALL OTHER KEYPAD BUTTONS FEEL NORMAL AND CLICK AS EXPECTED. THE PATIENT CONFIRMED THAT THE RUBBER KEYPAD IS INTACT; STATED THAT THE PUMP HAS BEEN EXPOSED TO POOL WATER; AND STATED THAT SHE CLEANS THE PUMP WITH RUBBING ALCOHOL.

    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 21 YR