BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 2072736 · Received March 31, 2011

    Report

    Report Number
    2531779-2011-02151
    Event Type
    Malfunction
    Date Received
    March 31, 2011
    Date of Event
    February 4, 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
    VA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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

    KEYPAD BUTTON PRESSES DO NOT ACTIVATE INTENDED PUMP RESPONSES. THE PATIENT STATED THAT ALL KEYPAD BUTTONS HAVE BECOME DIFFICULT TO PRESS OVER THE PAST MONTH. HE NOTED THAT ALL KEYPAD BUTTONS REQUIRE EXCESSIVE FORCE TO OBTAIN A RESPONSE, BUT STATED THAT THE AUDIO BOLUS BUTTON STILL WORKS AS EXPECTED. THE PATIENT REPORTED THAT THE BUTTONS STILL SPRING BACK AS EXPECTED, BUT DO NOT CLICK WHEN PRESSED. HE DENIED PHYSICAL DAMAGE TO THE RUBBER KEYPAD; STATED THAT THE PUMP HAS PREVIOUSLY BEEN EXPOSED TO WATER WHILE SWIMMING; AND STATED THAT HE 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 Male