BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1983266 · Received February 2, 2011

    Report

    Report Number
    2531779-2011-00684
    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
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVAL. INVESTIGATION REVEALED THAT THE KEYPAD APPEARED TO BE INTACT; HOWEVER, THE UP/DOWN/OK/CONTRAST ARROW BUTTONS WERE INTERMITTENTLY RESPONDING TO USER INPUTS AND REQUIRED EXCESSIVE FORCE TO ACTIVATE DURING TESTING, THE UP/DOWN KEY CONTACTS WERE MISALIGNED, THE CONTRAST KEY CONTACT WAS INVERTED, THE UP/DOWN/OK KEY CONTACTS BECAME INVERTED WHEN PRESSED, AND THERE WAS EVIDENCE OF CONTAMINATION UNDER ALL KEYPAD KEY CONTACTS.

    Description of Event or Problem · 1

    THE PT'S MOM CLAIMED THAT THE UP/DOWN/OK BUTTONS REQUIRED SEVERAL PRESSES TO ACTIVATE THE DESIRED PUMP FUNCTIONS. THE KEYPAD IS REPORTEDLY INTACT AND HAS NOT BEEN EXPOSED TO MOISTURE. 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