BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 2063203 · Received April 12, 2011

    Report

    Report Number
    2531779-2011-02495
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 16, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, 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. IT WAS CONFIRMED THAT THE BUTTON SYMBOLS ARE WORN. THE UP ARROW KEYPAD BUTTON WAS INTERMITTENTLY RESPONSIVE DURING TESTING. DURING INVESTIGATION, THE UP ARROW KEY CONTACT WAS OBSERVED TO BE MISALIGNED.

    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 BEEN INTERMITTENTLY UNRESPONSIVE. SHE NOTED THAT THE UP ARROW BUTTON DOES NOT CLICK WHEN PRESSED; THE UP ARROW AND OK KEYPAD BUTTON SYMBOLS ARE WORN; AND THE RUBBER KEYPAD IS WORN THIN. THE PATIENT DENIED EXPOSING THE PUMP TO WATER; AND STATED THAT SHE CARRIES THE PUMP ON 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 46 YR