BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3974354 · Received August 1, 2014

    Report

    Report Number
    3004209178-2014-88879
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP DID FUNCTION PROPERLY DURING FUNCTIONAL CHECK INCLUDING REWIND AND BASIC OCCLUSION, OCCLUSION, PRIME, EXCESSIVE NO DELIVERY, DISPLACEMENT, SELF TEST, AND AN ERROR TEST. THE OPERATING CURRENTS WERE NORMAL. NO MOISTURE DAMAGE INSIDE THE DEVICE NOTED. THE UNIT WAS RECEIVED WITH MINOR SCRATCHED DISPLAY WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNERS, CRACKED RESERVOIR TUBE LIP AND CRACKED BATTERY TUBE THREADS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS PUSHED INTO A POOL AND WAS WEARING THE INSULIN PUMP. CUSTOMER STATED SHE RUN A SELF TEST AND IT PASSED. CUSTOMER STATED THE INSULIN PUMP HAS NOT MALFUNCTIONED YET BUT IS CONCERNED IT COULD DUE TO BEING INTO THE WATER. BLOOD GLUCOSE 503 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450312 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR