BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 3943035 · Received July 17, 2014

    Report

    Report Number
    3004209178-2014-87703
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 17, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    P120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS CAME BACK SHOWING ALL BUTTONS FUNCTIONING PROPERLY. HOWEVER, FOUND UNLOCKED J2/LCD KEYPAD CONNECTOR DURING VISUAL INSPECTION. PUMP RECEIVED WITH CRACKED CASE AT THE WINDOW DISPLAY WINDOW CORNER, CRACKED RESERVOIR TUBE LIP AND SCRATCHED LCD WINDOW.

    Description of Event or Problem · 1

    CUSTOMER CALLED STATING SHE IS HAVING A LOT OF DIFFICULTY PRESSING THE UP ARROW ON HER INSULIN PUMP. HER FINGER IS SORE DUE TO THE PRESSURE REQUIRED TO PRESS THE BUTTON. CUSTOMER'S BLOOD GLUCOSE LEVEL IS 135 MG/DL. THERE WERE NO SIGNIFICANT EVENTS LEADING TO THE ALARM. THE DEVICE WAS NOT EXPOSED TO MOISTURE. CUSTOMER WAS ADVISED THAT THE DEVICE NEEDS TO BE REPLACED, AND TO DISCONTINUE USE AND REVERT TO A BACK UP PLAN. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419212 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR