BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2233209 · Received September 2, 2011

    Report

    Report Number
    2531779-2011-06450
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Report Date
    August 5, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS. ADHESIVE WAS FOUND UNDER THE KEYPAD BUTTON CONTACTS. ALL BUTTONS WERE INTERMITTENTLY ACTIVATING PUMP FUNCTIONS WHEN PRESSED. UNRELATED TO THE COMPLAINT THE BATTERY COMPARTMENT WAS FOUND TO BE CRACKED AND MOISTURE WAS FOUND INSIDE THE BATTERY COMPARTMENT. 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. 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

    THE PATIENT REPORTED THAT THE KEYPAD BUTTONS DID NOT ACTIVATE DESIRED PUMP FUNCTIONS WHEN PRESSED. HE DOES NOT SAY WHICH BUTTONS WERE AFFECTED. THERE WAS NO REPORTED PATIENT IMPACT ASSOCIATED WITH THIS COMPLAINT.

    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 53 YR