BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4233687 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-49070
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    September 8, 2014
    Report Date
    October 10, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 WAS HOSPITALIZED DUE TO LOW BLOOD GLUCOSE AND HAVING A SEIZURE. CUSTOMER'S BLOOD GLUCOSE WAS 13 MG/DL. CUSTOMER'S CURRENT BLOOD GLUCOSE AT THE TIME OF CALL WAS 206 MG/DL. THE DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER STATED HE DOES HAVE HIGHS BUT IT'S BECAUSE HE TRIES TO AVOID GOING LOW. CUSTOMER WAS WATCHING TV PRIOR TO BEING HOSPITALIZED. CUSTOMER WAS DISCONNECTED RUING REWIND OR PRIME SEQUENCE. CUSTOMER STATED THE BASAL RATES AND BOLUS HISTORY APPEARED CORRECT IN THE INSULIN PUMP. CUSTOMER STATED THERE WAS MORE INSULIN IN THE RESERVOIR THAN THE SCREEN SHOWED. THE DEVICE WAS NOT EXPOSED TO AN MRI. CUSTOMER WAS ADVISED TO MONITOR THE DEVICE AND REVERT TO BACK UP PLAN. CUSTOMER WENT ON STATING THE DEVICE OVER DELIVERED WHILE CUSTOMER WAS SLEEPING. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715177 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Hospitalization