BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 2091225 · Received April 20, 2011

    Report

    Report Number
    2531779-2011-02708
    Event Type
    Malfunction
    Date Received
    April 20, 2011
    Date of Event
    March 23, 2011
    Report Date
    March 23, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT RETURNED TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVAL SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    KEYPAD BUTTON PRESSES DO NOT ACTIVATE INTENDED PUMP RESPONSE. A FAMILY MEMBER REPORTED THAT THE OK KEYPAD BUTTON BECAME STUCK DURING PRIMING OF THE PUMP, AND THE PUMP CONTINUED TO PRIME AFTER THE OK BUTTON WAS RELEASED. SHE NOTED THAT THE PT WAS DISCONNECTED FROM THE INFUSION SET DURING PRIMING, AND THERE WAS NO REPORTED ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THE FAMILY MEMBER STATED THAT SHE HAD TO PRESS THE OK BUTTON MULTIPLE TIMES WITH EXCESSIVE FORCE TO GET IT TO RELEASE AND STOP PRIMING. SHE REPORTED THAT ALL OTHER KEYPAD BUTTONS FEEL NORMAL AND CLICK WHEN PRESSED. THE FAMILY MEMBER CONFIRMED THAT THE KEYPAD IS INTACT; AND DENIED EXPOSING THE PUMP TO WATER AND CLEANING PRODUCTS.

    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 12 YR