BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4211840 · Received October 29, 2014

    Report

    Report Number
    2032227-2014-44857
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    September 29, 2014
    Report Date
    September 30, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITIALIZED DUE TO HIGH BLOOD GLUCOSE. THE CUSOTMER'S BLOOD LEVEL WAS UNKNOWN MG/DL. THE CUSTOMER WAS IN A NEW INSULIN PUMP AND HAD PROBLEMS WITH HIGH AND LOW BLOOD GLUCOSE. THE CUSTOMER STATED THAT SHE WAS NOT FAMILIAR WITH THE NEW INSULIN PUMPS AND WORRIED MAY NOT BE PROPERLY TREATING DIABETES. THE CUSTOMER WAS ADVISED TO CALL BACK WHEN THEY CAN TROUBLESHOOT TO MAKE SURE INSULIN PUMP IS PROPERLY WORKING. NO FUTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691632 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization