BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4132252 · Received October 1, 2014

    Report

    Report Number
    2032227-2014-31024
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    August 31, 2014
    Report Date
    September 1, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S BLOOD GLUCOSE WERE RUNNING IN THE 50 TO 59 MG/DL RANGE. THE CUSTOMER STATED THAT HE ATE ABOUT 50 GRAMS OF CARBOHYDRATES, HIS BLOOD GLUCOSE WENT UP TO 178 MG/DL, AND THEN HIS BLOOD GLUCOSE WENT BACK DOWN TO 55 MG/DL. HE STATED HIS BLOOD GLUCOSE WAS THEN 126 MG/DL. THE CUSTOMER DECLINED TROUBLESHOOTING AS HE HAD DONE SO A WEEK PRIOR AND EVERYTHING TESTED FINE AT THAT POINT. THE CUSTOMER WAS ADVISED TO CONTACT HIS HEALTHCARE PROVIDER TO POSSIBLE GO OVER BASAL RATES. A BLOOD GLUCOSE OF 72 MG/DL WAS CAPTURED AT THE TIME OF THE REPORT. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612122 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR