BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3982228 · Received August 5, 2014

    Report

    Report Number
    3004209178-2014-90148
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 5, 2014
    Report Date
    July 5, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK
    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 PASSED THE DISPLACEMENT, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME, NO DELIVERY AND MOTOR TESTS. NO EXCESSIVE NO DELIVERY ALARM WAS NOTED. THE INSULIN PUMP HAD MINOR SCRATCHES ON THE DISPLAY WINDOW, CRACKED DISPLAY WINDOW CORNER, CRACKED BATTERY TUBE THREADS, A BROKEN RESERVOIR TUBE LIP AND A CRACKED RESERVOIR TUBE WINDOW.

    Description of Event or Problem · 1

    CUSTOMER CALLED REPORTING A MOTOR ERROR AND NO DELIVERY ALARM. CUSTOMER'S BLOOD GLUCOSE IS 170 MG/DL. THE MOTOR ERROR OCCURRED DURING BOLUS. CUSTOMER HAS DROPPED THE DEVICE IN THE PAST. IT WAS NOT EXPOSED TO A STRONG MAGNETIC FIELD. CUSTOMER USES THE SENSOR FUNCTION. SHE WAS ADVISED THAT A FALSE MOTOR ERROR MAY BE CAUSED BY VIEWING THE SENSOR GLUCOSE GRAPH DURING A BOLUS DELIVERY. CUSTOMER CAN REWIND THE DEVICE. DURING TROUBLESHOOTING, WHEN CUSTOMER REINSERTED THE RESERVOIR BACK INTO THE DEVICE, THE TOP OF THE COMPARTMENT POPPED OUT. TROUBLESHOOTING WAS STOPPED TO PREVENT ANY FURTHER PHYSICAL DAMAGE. CUSTOMER WAS ADVISED THE DEVICE NEEDS TO BE REPLACED, AND TO DISCONTINUE USE AND REVERT TO A BACK UP PLAN. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456921 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR