BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4022221 · Received August 19, 2014

    Report

    Report Number
    3004209178-2014-95661
    Event Type
    Malfunction
    Date Received
    August 19, 2014
    Date of Event
    July 20, 2014
    Report Date
    July 20, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT ALL THE OPERATING CURRENTS WERE WITHIN THE SPECIFICATION. NO UNEXPECTED LOW BATTERY, OFF NO POWER OR FAILED BATTERY TEST ALARM NOTED. THE INSULIN PUMP WAS MONITORED FOR TWENTY FOUR HOURS WITH MULTIPLE BASAL RATES. NO BLANK DISPLAY NOTED. THE UNIT PASSED THE ERROR TEST. NO UNEXPECTED RESTART OBSERVED. THE DEVICE WAS RECEIVED WITH MINOR SCRATCHED DISPLAY WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNERS AND CRACKED RESERVOIR TUBE LIP. NO MOISTURE DAMAGE INSIDE THE INSULIN PUMP NOTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE INSULIN PUMP HAD BEEN TURNING OFF BY ITSELF. CUSTOMER ALSO REPORTED RECEIVING A FAILED BATTERY TEST ON THE INSULIN PUMP THE DAY BEFORE THE CALL. CUSTOMER DOES NOT SHOW ANY SIGNS OF PHYSICAL DAMAGE AND HAS NOT RECENTLY BEEN EXPOSED TO MOISTURE. BLOOD GLUCOSE LEVEL AT THE TIME OF THE CALL WAS NOT PROVIDED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498509 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAL B2723NALJ

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR