BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3223120 · Received July 12, 2013

    Report

    Report Number
    3004209178-2013-95618
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 21, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    NO BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. UNABLE TO PERFORM FUNCTIONAL TEST INCLUDING DISPLACEMENT, PRIME, BASIC OCCLUSION, OCCLUSION AND NO DELIVERY TESTS DUE TO NO BUTTON RESPONSE. THE INSULIN PUMP WAS TESTED WITH TEST KEYPAD AND NO FROZEN SCREEN NOTED.

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD PROBLEMS WITH THE INSULIN PUMP, AND THE BUTTONS WERE FREEZING FOR THE PAST TWO WEEKS. THE CALLER STATED THAT IN ONE OCCASION THE CUSTOMER'S BLOOD GLUCOSE WAS VERY LOW AND HAD TO CALL THE PARAMEDICS. TROUBLESHOOTING WAS PERFORMED, AND FOUND A BUTTON ERROR IN THE ALARM HISTORY. WHILE THE MOTHER WAS ON THE PHONE, THE CUSTOMER ATTEMPTED TO DO A FILL CANNULA TEST AND THE NUMBERS WERE RAMPING BY THEMSELVES. ADVISED THE CALLER THAT THE INSULIN PUMP WOULD BE REPLACED AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322921 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Required Intervention