BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3920827 · Received July 8, 2014

    Report

    Report Number
    3004209178-2014-86624
    Event Type
    Injury
    Date Received
    July 8, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 20, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING ADMITTED IN THE INTENSIVE CARE UNIT WITH HIGH BLOOD GLUCOSE OF 700 FOR A DAY OR TWO AND WAS TREATED WITH AN INSULIN DRIP. THE CUSTOMER MENTIONED HAVING A LOT OF MEDICAL ISSUES, AND SHE COULD NOT LOWER DOWN HER GLUCOSE LEVEL. OFFERED TO TROUBLESHOOT THE DEVICE AND THE CUSTOMER STATED THAT EVERYTHING WAS FINE. ADVISED THE CUSTOMER TO CALL BACK FOR ANY ISSUES. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398248 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization