BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 2073124 · Received March 23, 2011

    Report

    Report Number
    2531779-2011-01885
    Event Type
    Malfunction
    Date Received
    March 23, 2011
    Date of Event
    February 25, 2011
    Report Date
    February 25, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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. IT WAS OBSERVED THAT ALL BUTTON KEY CONTACTS DO NOT 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 UNRESPONSIVE. THE PT REPORTED THAT THE DOWN ARROW KEYPAD BUTTON IS UNRESPONSIVE. SHE NOTED THAT THE KEYPAD BUTTONS DO NOT SPRING BACK WHEN PRESSED. THE PT STATED THAT THE RUBBER KEYPAD IS INTACT, THE PUMP IS EXPOSED TO WATER WHEN SHE SWIMS, AND SHE WEARS THE PUMP ON HER WAIST WITH A CLIP.

    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 32 YR