BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 2063096 · Received April 12, 2011

    Report

    Report Number
    2531779-2011-02496
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    March 7, 2011
    Report Date
    March 16, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE KEYPAD BUTTONS WERE INTERMITTENTLY UNRESPONSIVE. A CDE REPORTED THAT THE KEYPAD BUTTONS HAVE BEEN INTERMITTENTLY UNRESPONSIVE FOR 9 DAYS. SHE NOTED THAT THE BUTTONS FEEL FLAT WHEN PRESSED, AND THAT THE PUMP APPEARS WORN IN GENERAL. THE CDE CONFIRMED THAT THE RUBBER KEYPAD IS INTACT; AND STATED THAT THE PT WEARS THE PUMP IN HIS POCKET.

    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 14 YR