BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 2070844 · Received April 15, 2011

    Report

    Report Number
    2531779-2011-02587
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    March 17, 2011
    Report Date
    March 19, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, 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 KEYPAD BUTTON WAS INTERMITTENTLY RESPONSIVE DURING TESTING. IT WAS OBSERVED THAT NONE OF THE BUTTONS CLICK AND SPRING BACK WHEN PRESSED. DURING INVESTIGATION, THE UP ARROW, DOWN 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 UNRESPONSIVE. THE PT REPORTED THAT THE KEYPAD BUTTONS HAVE BEEN SLOW TO RESPOND FOR THE PAST COUPLE OF DAYS, AND NOW THE UP ARROW KEYPAD BUTTON IS NOT RESPONDING. SHE NOTED THAT THE PUMP GOT WET 3 WEEKS AGO. THE PT DENIED PHYSICAL DAMAGE TO THE KEYPAD; STATED THAT THE BUTTONS DO NOT CLICK AND SPRING BACK; DENIED EXPOSING THE PUMP TO CLEANING PRODUCTS; AND STATED THAT SHE 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 CORPORATION ONE TOUCH PING

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR