BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3920843 · Received July 8, 2014

    Report

    Report Number
    3004209178-2014-86571
    Event Type
    Injury
    Date Received
    July 8, 2014
    Date of Event
    April 24, 2014
    Report Date
    June 24, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP PASSED FUNCTIONAL TESTING INCLUDING THE REWIND, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME TEST, EXCESSIVE NO DELIVERY TEST AND DISPLACEMENT TEST. NO UNEXPECTED BATTERY OUT LIMIT ALARMS NOTED. INSULIN PUMP RECEIVED WITH INTERMITTENT BUTTONS DUE TO CORRODED KEYPAD TRACES AND CORRODED BATTERY TUBE. INSULIN PUMP RECEIVED WITH CRACKED CASE AT DISPLAY WINDOW CORNERS, RESERVOIR TUBE AND BATTERY TUBE THREADS, MINOR SCRATCHES ON DISPLAY WINDOW, MISSING END CAP STICKER AND STRIPPED BATTERY CAP COIN SLOT.

    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 BY THE CUSTOMER THAT THE BUTTONS ON HER INSULIN PUMP WERE UNRESPONSIVE. CUSTOMER WAS IN THE HOSPITAL DUE TO A DIABETES RELATED AMPUTATION PERFORMED EIGHT WEEKS EARLIER. CUSTOMER STATED NONE OF THE BUTTONS ARE RESPONDING AND DOES NOT RECALL ANY SIGNIFICANT EVENTS THAT LEAD TO THE ISSUE. PATIENT'S BLOOD GLUCOSE LEVEL WAS 182 MG/DL AT TIME OF REPORTING. ADVISED CUSTOMER TO DISCONTINUE USE OF DEVICE AND REVERT TO HEALTHCARE PROVIDER'S INSTRUCTIONS. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398397 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization