BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3941799 · Received July 17, 2014

    Report

    Report Number
    3004209178-2014-87499
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 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

    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.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP RECOGNIZED A RESERVOIR WITH NO RESERVOIR INSTALLED DURING THE DISPLACEMENT TEST AND ALARMED NO DELIVERY DUE TO DRIED INSULIN ON MOTOR SLIDE AND INSIDE RESERVOIR TUBE. UNABLE TO PERFORM DISPLACEMENT TEST OR VERIFY MOTOR ERROR ALARMS DUE TO EXCESSIVE NO DELIVERY ALARMS. THE MOTOR WAS TESTED OUTSIDE THE DEVICE AND PASSED. THE INSULIN PUMP RECEIVED WITH CRACKED CASE AT DISPLAY WINDOW CORNERS, CRACKED RESERVOIR TUBE, CRACKED BATTERY TUBE THREADS AND MINOR SCRATCHES ON LCD WINDOW.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A MOTOR ERROR ALARM. THE BLOOD GLUCOSE READING WAS 168 MG/DL. THERE WERE NO SIGNIFICANT EVENTS LEADING TO THE ALARM. THE PATIENT STATED THAT THE INSULIN PUMP WAS NOT EXPOSED TO A STRONG MAGNETIC FIELD OR AN MRI. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO A BACK UP PLAN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419779 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR