BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 2042880 · Received March 30, 2011

    Report

    Report Number
    2531779-2011-02095
    Event Type
    Malfunction
    Date Received
    March 30, 2011
    Date of Event
    March 2, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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

    KEYPAD BUTTON PRESSES DO NOT ACTIVATE INTENDED PUMP RESPONSE. THE PATIENT REPORTED THAT THE UP ARROW, DOWN ARROW, AND OK KEYPAD BUTTONS HAVE REQUIRED EXCESSIVE FORCE TO OBTAIN A RESPONSE AND SOMETIMES STICK FOR THE PAST 3 MONTHS. HE ALSO REPORTED THAT THE CONTRAST BUTTON HAS BEEN UNRESPONSIVE FOR THE PAST 3 MONTHS. THE PATIENT NOTED THAT THE BUTTONS DO NOT ALWAYS SPRING BACK, AND SOMETIMES THEY SPRING BACK MORE SLOWLY THAN EXPECTED. THE PATIENT REPORTED THAT ON ONE INSTANCE OF PRIMING THE PUMP, HE RELEASED THE BUTTON AND THE PUMP CONTINUES TO PRIME. HE STATED THAT HE HAD TO DISCONNECT THE CARTRIDGE AND EVENTUALLY WAS ABLE TO GET THE BUTTON UNSTUCK. THE PATIENT CONFIRMED THAT THE RUBBER KEYPAD IS INTACT; DENIED EXPOSING THE PUMP TO MOISTURE AND CLEANING PRODUCTS; AND STATED THAT HE WEARS THE PUMP IN HIS FRONT PANTS 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 21 YR