BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 2030707 · Received March 22, 2011

    Report

    Report Number
    2531779-2011-01798
    Event Type
    Malfunction
    Date Received
    March 22, 2011
    Date of Event
    January 22, 2011
    Report Date
    February 22, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE KEYPAD BUTTONS WERE STICKING AND INTERMITTENTLY UNRESPONSIVE. THE PT REPORTED THAT THE DOWN ARROW AND OK KEYPAD BUTTONS HAVE BEEN INTERMITTENTLY UNRESPONSIVE FOR THE PAST MONTH. SHE NOTED THAT THE BUTTONS DO NOT ALWAYS CLICK WHEN PRESSED, AND GET STUCK IN THE DOWN POSITION. THE PT DENIED PHYSICAL DAMAGE TO THE RUBBER KEYPAD; DENIED EXPOSING THE PUMP TO WATER; AND STATED THAT SHE WEARS THE PUMP IN HER POCKET OR ON THE INSIDE OF HER BRA.

    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 16 YR