BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2180013 · Received July 27, 2011

    Report

    Report Number
    2531779-2011-05270
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Report Date
    June 28, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS 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. THE SUBJECT PUMP WAS INVESTIGATED WITH THE FOLLOWING FINDINGS: TESTING CONFIRMED INTERMITTENT RESPONSES TO BUTTON PRESSES ON THE UP, DOWN, AND OK BUTTONS. MULTIPLE BUTTON PRESSES REQUIRING INCREASING FORCE ARE REQUIRED BEFORE THE BUTTONS WILL ENGAGE. NO VISIBLE EVIDENCE OF MOISTURE BEHIND DISPLAY LENS. AN IN-HOUSE LEAK TEST WAS PERFORMED AND FOUND A DISPLAY LENS LEAK. EVIDENCE OF MOISTURE DAMAGE(CORROSION) WAS FOUND INSIDE THE BATTERY CHAMBER. REMOVED KEYPAD COVER TO CHECK CONDITION OF THE BUTTON CONTACTS. CONTAMINATION WAS PRESENT UNDER THE CONTACTS OF ALL BUTTONS.

    Description of Event or Problem · 1

    THE PATIENT CLAIMED THAT ALL THE BUTTONS REQUIRED SEVERAL PRESSES TO ACTIVATE THE DESIRED PUMP FUNCTIONS. THE PATIENT ALSO MENTIONED THAT THE LENS PROTECTOR PEELED OFF. 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 27 YR