BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 5706808 · Received June 8, 2016

    Report

    Report Number
    3004209178-2016-52447
    Event Type
    Injury
    Date Received
    June 8, 2016
    Date of Event
    May 16, 2016
    Report Date
    May 19, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    OTHER

    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

    THE CUSTOMER REPORTED VIA PHONE CALL THAT HE WENT TO THE DOCTOR YESTERDAY AND THE DOCTOR MOVED SOME OF THE SETTINGS AROUND ON THE INSULIN PUMP. CUSTOMER STATED THAT HIS BLOOD GLUCOSE WENT HIGH AFTER THE DOCTOR MADE CHANGES TO THE SETTINGS. CUSTOMER'S BLOOD GLUCOSE WAS 500 MG/DL. CUSTOMER WAS ASSISTED WITH CHANGING THE CARB RATIOS DOWN TO 5.0 AND THE SENSITIVITY DOWN TO 20. CUSTOMER DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE SINCE HE KNOWS IT WAS DUE TO THE CHANGES THE DOCTOR MADE. CUSTOMER STATED THAT HE TOLD HIS DOCTOR AND HIS DOCTOR TOLD HIM TO CALL THE HELPLINE AND CHANGE THE SETTING BACK DOWN TO WHAT THEY WERE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360666 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 55 YR Other