BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3801105 · Received May 8, 2014

    Report

    Report Number
    3004209178-2014-84511
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 23, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING, IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS. THE DEVICE COMMUNICATED WITH THE TRANSMITTER AND GLUCOMETER PROPERLY. PROGRAMMED SENSOR GLUCOSE VALUES REGISTERED PROPERLY. NO DAMAGE TO THE KEYPAD ASSEMBLY OR FROZEN DISPLAY NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP IS HAVING PROBLEMS. THE INSULIN PUMP HAS FROZEN TWICE AND CUSTOMER HAS REMOVED THE BATTERY. CUSTOMER HAS DISCOVERED BENT CANNULAS. THE CURRENT BLOOD GLUCOSE READING IS 300 MG/DL. ATTEMPTED TO TREAT THE HIGH WITH THE INSULIN PUMP, BUT THE BUTTONS DO NOT RESPOND. THE INSULIN PUMP IS FROZEN WITH NO ADVANCEMENT OF TIME. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277627 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 42 YR