BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3972297 · Received July 31, 2014

    Report

    Report Number
    3004209178-2014-88817
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 2, 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 Location
    WI
    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 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

    IT WAS REPORTED THE CUSTOMER HAD HIGH BLOOD GLUCOSE OF 382 MG/DL. CUSTOMER'S MOTHER CHANGED OUT ENTIRE SET. SHE STATED THAT THE CUSTOMER'S BLOOD GLUCOSE LOWERED TO 49 MG/DL TREATED WITH APPLE JUICE AND CANDY, IT WENT UP TO 95 MG/DL. SHE NOTICED THE CANNULA OF THE INFUSION SET WAS BENT. TROUBLESHOOTING WAS PERFORMED. CUSTOMER'S MOTHER WAS ADVISED TO DISCONNECT THE DEVICE FROM THE CUSTOMER. THE DEVICE SUPPORT CAP APPEARS NORMAL. CUSTOMER WAS DISCONNECTED DURING MANUAL PRIME SEQUENCE. SHE REVIEWED SETTINGS AND HISTORY; FOUND DAILY TOTALS WERE FOUR UNITS HIGHER. SHE REPORTED THAT THE CUSTOMER HAD DISCONNECTED A FEW TIMES FROM THE DEVICE BECAUSE HE WAS SWIMMING. FOUND THAT RESERVOIR SHOWED 100 UNITS OF INSULIN AND THE DEVICE DISPLAY 63.8 UNITS. FOUND A LOT OF OVER BOLUS FOR HIGH BLOOD GLUCOSE. NO MRI EXPOSURE. SHE WAS ADVISED TO SPEAK TO THE CUSTOMER'S DOCTOR IN REGARDS TO LOW BLOOD GLUCOSE AND TO MONITOR THE DEVICE. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447993 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR