BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3933149 · Received July 14, 2014

    Report

    Report Number
    3004209178-2014-86927
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 15, 2014
    Report Date
    June 15, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    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 RECEIVED WITH INTERMITTENT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. NO RAMPING NUMBERS ANOMALY NOTED. THE INSULIN PUMP RECEIVED WITH MINOR SCRATCHES ON DISPLAY WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNER, CRACKED BATTERY TUBE THREADS, CRACKED RESERVOIR TUBE LIP AND CRACKED RESERVOIR TUBE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BUTTONS ON THE INSULIN PUMP WERE UNRESPONSIVE AND THE NUMBERS WERE RAMPING ON THEIR OWN. THE CUSTOMER'S BLOOD GLUCOSE WAS 140 MG/DL. THE CUSTOMER WAS ADVISED TO DISCONTINUE THE USE OF THE DEVICE AND TO REVERT TO A BACK-UP PLAN. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409214 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR