BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 2072706 · Received March 31, 2011

    Report

    Report Number
    2531779-2011-02115
    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
    FL, 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 DOWN ARROW AND OK KEYPAD BUTTONS WERE INTERMITTENTLY RESPONSIVE DURING TESTING. THE UP ARROW AND CONTRAST KEYPAD BUTTONS REQUIRED EXCESSIVE FORCE TO OBTAIN A RESPONSE. DURING INVESTIGATION, THE DOWN ARROW KEY CONTACT WAS OBSERVED TO BE MISALIGNED. IT WAS OBSERVED THAT THE UP ARROW KEY CONTACT DOES NOT SPRING BACK WHEN PRESSED. THE DOWN ARROW, OK, AND CONTRAST 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. THE PATIENT REPORTED THAT THE UP ARROW KEYPAD BUTTON HAS REQUIRED MULTIPLE PRESSES TO OBTAIN A RESPONSE FOR THE PAST 2 WEEKS, AND TODAY THE UP ARROW KEYPAD BUTTON IS COMPLETELY UNRESPONSIVE. SHE NOTED THAT THE UP ARROW BUTTON DOES NOT CLICK WHEN PRESSED, BUT ALL OTHER KEYPAD BUTTONS FEEL NORMAL AND CLICK AS EXPECTED. THE PATIENT STATED THAT THE RUBBER KEYPAD IS INTACT; AND DENIED EXPOSING THE PUMP TO WATER AND CLEANING PRODUCTS.

    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 57 YR