BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 2070861 · Received April 15, 2011

    Report

    Report Number
    2531779-2011-02591
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    December 20, 2011
    Report Date
    March 20, 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 WERE INTERMITTENTLY RESPONSIVE DURING TESTING. DURING INVESTIGATION, THE OK KEY CONTACT WAS OBSERVED TO BE MISALIGNED. IT WAS OBSERVED THAT NONE OF THE BUTTONS CLICK AND SPRING BACK AS EXPECTED WHEN PRESSED. 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 KEYPAD BUTTONS HAVE BEEN SLOW TO RESPOND FOR THE (B)(6), AND NOW THE BUTTONS ARE INTERMITTENTLY UNRESPONSIVE. HE NOTED THAT THE BUTTONS DO NOT CLICK AND SPRING BACK WHEN PRESSED. THE PT DENIED PHYSICAL DAMAGE TO THE KEYPAD; DENIED EXPOSING THE PUMP TO WATER AND CLEANING PRODUCTS; AND STATED THAT HE WEARS THE PUMP IN VARIOUS PLACES 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 CORP. ONE TOUCH PING

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR