BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULININFUSION PUMP

    MDR report key: 4142990 · Received September 27, 2014

    Report

    Report Number
    2032227-2014-27437
    Event Type
    Injury
    Date Received
    September 27, 2014
    Date of Event
    August 26, 2014
    Report Date
    August 29, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER IS EXPERIENCED A HIGH BLOOD GLUCOSE LEVEL OF 400 MG/DL, WHICH SHE TREATED WITH A MANUAL INJECTION. CUSTOMER CURRENT BLOOD GLUCOSE IS 280 MG/DL. TROUBLESHOOTING FOR THE HIGH BLOOD GLUCOSE LEVEL WAS ABOUT TO BE PERFORMED, AND DETERMINED THE INSULIN PUMP IS WORKING AS DESIGNED. DRIVE SUPPORT CAP WAS RECESSED AND THE INSULIN PUMP PASSED THE HIGH PRESSURE TEST. AN OCCLUSION WAS FOUND AND CUSTOMER WAS ADVISED CHANGE THE SET AND RESERVOIR. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603683 PARADIGM REAL-TIME REVEL INSULININFUSION PUMP OYC MEDTRONIC MINIMED MMT-523RNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention