BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4170834 · Received October 14, 2014

    Report

    Report Number
    2032227-2014-37852
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 15, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    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

    AFTER BATTERY INSTALLATION, INSULIN PUMP POWERED UPS AN ALARMED FAILED BATTERY TEST DUE TO FAULTY BATTERY TUBE. INSULIN PUMP FUNCTIONED PROPERLY AFTER UNPLUGGING AND PLUGGING THE BATTERY TUBE CONNECTOR INTO INTERFACE BOARD. INSULIN PUMP WAS MONITORED AND NO BLANK DISPLAY ANOMALIES WERE NOTED. NO DAMAGE ON THE CONNECTOR LCD ISOLATION TAPE NOTED. UNABLE TO CONFIRM UNEXPECTED LOW BATTERY ALARM, DUE TO FAILED BATTERY TEST ALARMS. INSULIN PUMP RECEIVED WITH CRACKED CASE AT DISPLAY WINDOW CORNERS, RESERVOIR TUBE LIP, BATTERY TUBE THREADS AND MINOR SCRATCHES ON DISPLAY WINDOW. NO PHYSICAL DAMAGE FOUND ON BATTERY CAP.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THEIR INSULIN PUMP HAD A BLANK DISPLAY AND ALARMED. DURING TROUBLESHOOTING, CUSTOMER WAS ASKED IF THE DEVICE SHOW PHYSICAL DAMAGE AND CUSTOMER STATED IT DOES NOT. NEXT, CUSTOMER WAS ASKED IF THE BATTERY COMPARTMENT APPEARED DAMAGED. CUSTOMER STATED IT DOES NOT. AFTERWARDS, CUSTOMER WAS ADVISED TO REINSERT NEW BATTERIES. CUSTOMER STATED DISPLAY DID RETURN. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 292 MG/DL AT TIME OF REPORTING. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649695 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 45 YR