BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP.

    MDR report key: 4212487 · Received October 27, 2014

    Report

    Report Number
    2032227-2014-43421
    Event Type
    Injury
    Date Received
    October 27, 2014
    Date of Event
    September 26, 2014
    Report Date
    September 26, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNK 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

    THE CUSTOMER REPORTED HIGH BLOOD GLUCOSE. CUSTOMER'S BLOOD GLUCOSE WAS 448 MG/DL. CUSTOMER STATED THAT HER DOCTOR MADE ADJUSTMENTS ON HER INSULIN PUMP DUE TO HER BLOOD GLUCOSE WAS GOING DOWN BUT CURRENTLY HER BLOOD GLUCOSE WAS TOO HIGH. CUSTOMER TREATED WITH MANUAL INJECTION BECAUSE SHE WAS NOT FEELING WELL. CUSTOMER DECLINED TO TROUBLESHOOT FOR HIGH BLOOD GLUCOSE AND NEEDED ASSISTANCE TO ADJUST BASAL RATES. ADVISED THE CUSTOMER TO CHECK WITH HEALTH CARE PROVIDER REGARDING DIRECTION AS WHAT TO CHANGE IN THE SETTINGS. NO FURTHER INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684444 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP. OYC OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR