BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 2091243 · Received April 20, 2011

    Report

    Report Number
    2531779-2011-02723
    Event Type
    Malfunction
    Date Received
    April 20, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 24, 2011
    Manufacturer
    ANIMAS CORP
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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 KEYPADS BUTTONS WERE INTERMITTENTLY RESPONSIVE DURING TESTING. IT WAS OBSERVED THAT THE KEYPAD BUTTONS DO NOT CLICK AND SPRING BACK WHEN PRESSED. DURING INVESTIGATION, THE UP ARROW AND OK KEY CONTACTS WERE OBSERVED TO BE MISALIGNED. THERE WAS EVIDENCE OF KEYPAD CONTAMINATION FOUND UNDER ALL KEY CONTACTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE KEYPAD BUTTONS WERE INTERMITTENTLY UNRESPONSIVE. THE PT REPORTED THAT THE DOWN ARROW KEYPAD BUTTONS HAS BEEN INTERMITTENTLY UNRESPONSIVE FOR THE (B)(6) AND REQUIRES NUMEROUS PRESSES TO OBTAIN A RESPONSE. SHE NOTED THAT ALL KEYPAD BUTTONS CLICK AND SPRING BACK AS EXPECTED WHEN PRESSED. THE PT DENIED PHYSICAL DAMAGE TO THE RUBBER KEYPAD; DENIED EXPOSING THE PUMP TO WATER; AND STATED THAT SHE WEARS THE PUMP IN HER BRA.

    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 42 YR