BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 2030378 · Received March 22, 2011

    Report

    Report Number
    2531779-2011-01802
    Event Type
    Malfunction
    Date Received
    March 22, 2011
    Date of Event
    December 22, 2010
    Report Date
    February 22, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVAL HAS NOT YET BEEN COMPLETED. WHEN EVAL 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 UNRESPONSIVE. A FAMILY MEMBER REPORTED THAT THE UP ARROW AND DOWN ARROW KEYPAD BUTTONS HAVE BECOME INCREASINGLY UNRESPONSIVE OVER THE PAST 2 MONTHS. HE NOTED THAT THE BUTTONS STILL CLICK AS EXPECTED WHEN PRESSED. THE FAMILY MEMBER DENIED PHYSICAL DAMAGE TO THE RUBBER KEYPAD; DENIED EXPOSING THE PUMP TO WATER; AND STATED THAT THE PT CARRIES THE PUMP IN A POCKET OR ON A CLIP ATTACHED TO HER WAIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONE TOUCH PING

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR