BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1983280 · Received February 2, 2011

    Report

    Report Number
    2531779-2011-00677
    Event Type
    Malfunction
    Date Received
    February 2, 2011
    Report Date
    January 6, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVAL AND EVALUATED. THE KEYPAD APPEARED TO BE INTACT; HOWEVER, THE DOWN ARROW AND OK BUTTONS WERE INTERMITTENTLY RESPONDING TO USER INPUTS AND THERE WAS EVIDENCE OF CONTAMINATION UNDER THE DOWN ARROW AND OK KEY CONTACTS.

    Description of Event or Problem · 1

    THE PT CLAIMED THAT THE PRIME STEP DID NOT IMMEDIATELY STOP WHEN THE OK BUTTON WAS PRESSED. SHE ALSO CLAIMED THAT THE KEYPAD BUTTONS FEEL LIKE THEY ARE STUCK DOWN. THE PATIENT DENIED EXPOSING THE PUMP TO MOISTURE AND INDICATED THAT THERE WAS NO EVIDENCE THAT THE KEYPAD WAS PEELING. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THE PUMP WAS REPLACED.

    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