BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 2070538 · Received March 29, 2011

    Report

    Report Number
    2531779-2011-02012
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Report Date
    February 28, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVAL. THE KEYPAD WAS FOUND TO BE INTACT; NO PEELING OR LIFTING WAS OBSERVED. THE DOWN ARROW AND OK KEYPAD BUTTONS WERE INTERMITTENTLY RESPONSIVE DURING TESTING. IT WAS ALSO FOUND THAT THE UP ARROW AND CONTRAST KEYPAD BUTTONS REQUIRED EXCESSIVE FORCE TO ACTIVATE A RESPONSE. DURING INVESTIGATION, THE CONTRAST BUTTON WAS OBSERVED TO BE MISALIGNED. ALL KEYPAD BUTTONS INTERMITTENTLY 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 UP ARROW IS WORKING INTERMITTENTLY. IT WAS REPORTED THAT THE KEYPAD IS NOT PEELING AND THE PUMP DOES NOT GET WET.

    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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1