BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4142328 · Received October 5, 2014

    Report

    Report Number
    2032227-2014-33692
    Event Type
    Injury
    Date Received
    October 5, 2014
    Date of Event
    August 30, 2014
    Report Date
    September 5, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    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

    CUSTOMER REPORTED THAT HE HAD RECENTLY SUFFERED A SEIZURE DUE TO LOW BLOOD GLUCOSE LEVELS. CUSTOMER REPORTED THAT PARAMEDICS WERE CALLED IN RESPONSE TO A BLOOD GLUCOSE LEVEL OF 24 MG/DL. CUSTOMER WAS TREATED WITH GLUCOSE SHOTS AND INTRAVENOUS GLUCOSE, THEN ADMITTED TO THE HOSPITAL. CUSTOMER REPORTED THAT HE HAD BEEN EXPERIENCING LOW BLOOD GLUCOSE LEVELS FOR APPROXIMATELY THREE TO FOUR WEEKS. TROUBLESHOOTING SHOWED THAT THE INSULIN PUMP WAS FUNCTIONING PROPERLY. BLOOD GLUCOSE LEVEL WAS 149 MG/DL AT THE TIME OF THE CALL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621869 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 44 YR Hospitalization