BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 2060746 · Received April 8, 2011

    Report

    Report Number
    2531779-2011-02194
    Event Type
    Malfunction
    Date Received
    April 8, 2011
    Date of Event
    February 18, 2011
    Report Date
    March 4, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 WAS REPORTED THAT THE KEYPAD BUTTONS WERE INTERMITTENTLY UNRESPONSIVE. THE PATIENT REPORTED THAT THE UP ARROW, DOWN ARROW, AND OK KEYPAD BUTTONS HAVE BECOME INCREASINGLY UNRESPONSIVE OVER THE PAST 2 WEEKS. SHE NOTED THAT THE BUTTONS FEEL FLAT AND DO NOT CLICK WHEN PRESSED. THE PATIENT DENIED PHYSICAL DAMAGE TO THE RUBBER KEYPAD; REPORTED THAT THE PUMP IS EXPOSED TO WATER IN THE SHOWER; AND STATED THAT SHE CARRIES THE PUMP IN HER BRA WITH A CLIP.

    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 31 YR