BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 5981737 · Received September 27, 2016

    Report

    Report Number
    2032227-2016-24245
    Event Type
    Injury
    Date Received
    September 27, 2016
    Date of Event
    June 16, 2016
    Report Date
    October 10, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. (B)(4).

    Additional Manufacturer Narrative · 1

    THE PUMP PASSED THE FUNCTIONAL TESTING, INCLUDING THE SELF-TEST, UNEXPECTED RESTART, DISPLACEMENT, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME, OFF NO POWER AND EXCESSIVE NO DELIVERY ALARM TESTS. ALL OPERATING CURRENTS WERE WITHIN SPECIFICATION. NO UNEXPECTED LOW BATTERY OR OFF NO POWER ALARMS WERE NOTED. THE PUMP WAS PROGRAMMED WITH A TEST MINI LINK AND THE GLUCOSE SENSOR SIMULATOR. THE PUMP COMMUNICATED PROPERLY WITH THE GLUCOSE SENSOR SIMULATOR AND DISPLAYED THE 100 VALUE PROPERLY ON THE DISPLAY GRAPH. NO LOST SENSOR ALARM WAS NOTED. THE PUMP WAS RECEIVED WITH INTERMITTENT BUTTON RESPONSE ON ALL THE BUTTONS DUE TO FLATTENED BUTTON DOME SWITCHES. NO UNLOCKED LCD KEYPAD CONNECTOR WAS NOTED DURING VISUAL INSPECTION. THE PUMP WAS RECEIVED WITHOUT A BELT CLIP, THEREFORE, UNABLE TO CONFIRM THE DAMAGE. THE BATTERY CAP COIN SLOT WAS STRIPPED. THE PUMP HAD A CRACKED RESERVOIR TUBE LIP, MINOR SCRATCHES ON THE DISPLAY WINDOW, A CRACKED CASE AT THE DISPLAY WINDOW CORNER, A CRACKED BELT CLIP SLOT, CRACKED BATTERY TUBE THREADS AND A SCRATCHED RESERVOIR TUBE WINDOW.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP KEYPAD BUTTONS ARE NOT RESPONSIVE AND THE BATTERY CAP IS HARD TO REMOVE. THE CUSTOMER'S BLOOD GLUCOSE READING WAS 578 MG/DL AT THE TIME OF INCIDENT. TROUBLESHOOTING FOUND THAT THE CUSTOMER DOESN'T KNOW IF THEIR SETTINGS WERE CHANGED AT A RECENT DOCTOR'S VISIT. THE CUSTOMER WAS ADVISED TO CHANGE OUT THEIR SET AND RESERVOIR AND TREAT PER THEIR DOCTOR'S INSTRUCTIONS. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO A BACK-UP PLAN PER THEIR DOCTOR'S INSTRUCTION. THE CUSTOMER WAS ALSO ADVISED THAT THE DEVICE WOULD BE REPLACED AND AGREED TO RETURN THE PRODUCT FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633701 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other