BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4200782 · Received October 24, 2014

    Report

    Report Number
    2032227-2014-42775
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Date of Event
    July 1, 2014
    Report Date
    September 25, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP HAD INTERMITTENT BUTTON RESPONSE DUE TO MOISTURE DAMAGE KEYPAD TRACE. THE INSULIN PUMP PASSED FUNCTIONAL TESTING. NO MOTOR ERROR ALARM. THE MOTOR PASSED MOTOR TEST. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHED LCD WINDOW, CRACKED CASE NEAR DISPLAY WINDOW CORNERS, BATTERY TUBE THREADS CRACKED, BROKEN BELT CLIP SLOT, CRACKED RESERVOIR TUBE LIP. NO UNEXPECTED ALARM WAS NOTED.

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED HE WAS HAVING SOME PROBLEMS WITH HIS PUMP OVER THE LAST FEW DAYS. THE DEVICE HAS BEEN ALARMING MOTOR ERROR AND NO DELIVERY. CUSTOMER'S BLOOD GLUCOSE WAS IN THE 200 MG/DL RANGE. ALARM AND POSSIBLE CAUSES WERE EXPLAINED TO THE CUSTOMER. NO DELIVERY ALARM WAS RESOLVED WITH A COMPLETE SET CHANGE. MOTOR ERROR ALARM OCCURRED DURING BOLUS. CUSTOMER DOES NOT RECALL ANY PREVIOUS SIGNIFICANT EVENT THAT MAY HAVE CAUSED THE DEVICE TO ALARM. THE DEVICE WAS NOT EXPOSED TO MRI. ALARM WAS CLEARED. CUSTOMER WAS ADVISED TO DISCONNECT FROM THE DEVICE. CUSTOMER DOES USE THE SENSOR FEATURE. CUSTOMER WAS ADVISED ABOUT FALSE MOTOR ERROR ALARMS OCCURRING, IF CUSTOMER TRIED TO SEE THE SENSOR GLUCOSE GRAPH WHILE BOLUSING. CUSTOMER WAS ABLE TO COMPLETE THE REWIND PROCESS. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679723 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR