BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3930889 · Received July 12, 2014

    Report

    Report Number
    3004209178-2014-86874
    Event Type
    Malfunction
    Date Received
    July 12, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    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 AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    CUSTOMER CALLED REPORTING HIGH BLOOD GLUCOSE LEVELS WHILE WEARING HIS INSULIN PUMP. HER BLOOD GLUCOSE LEVEL IS 600 MG/DL. CUSTOMER TREATED WITH A MANUAL INJECTION. HE EXPERIENCED NO SYMPTOMS OF HIGH BLOOD GLUCOSE LEVELS. THE DRIVE SUPPORT CAP APPEARED NORMAL. THERE WAS NO AIR IN THE TUBING. THE RESERVOIR WAS REMOVED AND THE DEVICE REWOUND. INSULIN EXITED THE TUBING DURING MANUAL PRIME. NO LEAKS WERE FOUND. THE DEVICE'S HISTORY WAS ACCURATE. CUSTOMER SAID THERE WAS A NO DELIVERY ALARM DURING BASAL DELIVERY, BUT SHE WAS ABLE TO REWIND AND PRIME THE DEVICE AND CLEAR THE ALARM. THE DEVICE PASSED THE HIGH PRESSURE TEST. CUSTOMER WAS ADVISED ON PROPER INSERTION AND SITE METHODS AND DIFFERENT INFUSION SETS. IF SHE NEEDS TO CHANGE HER SETTINGS, SHE WAS INSTRUCTED TO CONTACT HER DOCTOR. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408609 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR