BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 2030745 · Received March 22, 2011

    Report

    Report Number
    2531779-2011-01815
    Event Type
    Malfunction
    Date Received
    March 22, 2011
    Report Date
    February 23, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. THE KEYPAD WAS TORN BETWEEN THE DOWN AND OK KEYPAD BUTTONS. ALL KEYPAD BUTTONS REQUIRED EXCESSIVE FORCE TO ACTIVATE A RESPONSE DURING TESTING. ALL KEYPAD BUTTONS DO NOT 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 KEYPAD IS UNRESPONSIVE. THE PATIENT REPORTED THAT THE KEYPAD IS NOW TORN FROM HAVING TO CONTINUALLY PUSH BUTTONS TO GET THEM TO RESPOND. IT WAS REPORTED THAT THE PUMP IS NOT EXPOSED TO WATER.

    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