BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4244042 · Received November 11, 2014

    Report

    Report Number
    2032227-2014-50691
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 12, 2014
    Report Date
    October 13, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY
    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 INSULIN PUMP PASSED THE FUNCTIONAL TESTING AND NO BUTTON ERROR ALARM WAS NOTED. HOWEVER, THE INSULIN PUMP HAD INTERMITTENT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. NO DISPLAY ANOMALY WAS NOTED. THE INSULIN PUMP HAD MINOR SCRATCHES ON THE DISPLAY WINDOW, CRACKED BATTERY TUBE THREADS, A CRACKED RESERVOIR TUBE, CRACKED RESERVOIR TUBE WINDOW, AND A BROKEN RESERVOIR TUBE LIP. THE INSULIN PUMP HAD MOISTURE DAMAGE ON THE DISPLAY BOARD. NO MOISTURE DAMAGE OR INSULIN ODOR WAS NOTED IN THE RESERVOIR TUBE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE NUMBERS ON THE CUSTOMER'S INSULIN PUMP WERE CONTINUOUSLY SCROLLING BY THEMSELVES, A BUTTON WAS NOT WORKING, AND THE RESERVOIR WAS LEAKING INSULIN IN THE RESERVOIR CHAMBER. THE CUSTOMER EVENTUALLY RECEIVED A BUTTON ERROR ALARM. THE CUSTOMER'S BLOOD GLUCOSE WAS 350 MG/DL, WHICH WAS TREATED WITH A SHOT. SHE EXPERIENCED SYMPTOMS OF THIRST AND NOT FEELING WELL. NO SIGNIFICANT EVENTS LEADING TO THE KEYPAD ISSUES WERE RECALLED. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE AND REVERT TO A BACK-UP PLAN. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726346 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 34 YR