BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2173445 · Received July 23, 2011

    Report

    Report Number
    2531779-2011-05160
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Report Date
    June 27, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS FOR EVALUATION. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. PRODUCT ANALYSIS (PA) INVESTIGATED THE SUBJECT PUMP AND NOTED THE FOLLOWING : TESTING CONFIRMED INTERMITTENT RESPONSES TO BUTTON PRESSES ON THE OK BUTTON. THE PUMP WAS PLACED IN SUSPENSION AND THEN RESUME. THE OK BUTTON WORKED AFTER MULTIPLE PRESSES. PA CONFIRMED DAMAGE TO THE KEYPAD-THE KEYPAD IS TORN OVER THE OK BUTTON, EXPOSING THE BUTTON CONTACT. ALSO OBSERVED THE OK BUTTON CONTACT IS INVERTED. PA REMOVED KEYPAD COVER TO CHECK CONDITION OF THE BUTTON CONTACTS AND NOTICED CONTAMINATION WAS PRESENT UNDER THE CONTACTS OF ALL BUTTONS.

    Description of Event or Problem · 1

    THE PATIENT CLAIMED THAT THE OK BUTTONS DOES NOT RESPOND. THE KEYPAD IS REPORTEDLY INTACT. THERE WAS NO ADVERSE EVENT ASSOCIATE WITH THIS COMPLAINT. THE PUMP WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1