BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4123139 · Received September 26, 2014

    Report

    Report Number
    2032227-2014-29493
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    August 27, 2014
    Report Date
    August 27, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    OTHER

    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

    CUSTOMER REPORTED THAT THE CANNULA THAT WAS IN HER BODY WAS BENT AND WAS HOSPITALIZED. CUSTOMER'S BLOOD GLUCOSE READING AT THE TIME OF THE HOSPITALIZATION WAS 452 MG/DL. CUSTOMER REPORTED SYMPTOMS OF TIGHT THROAT AND STOMACH AND DEHYDRATION PRIOR TO THE HOSPITALIZATION. CUSTOMER'S INSULIN PUMP WAS SUSPENDED TWO HOURS AND FORTY FIVE MINUTES PRIOR TO THE HOSPITALIZATION. CUSTOMER WAS RELEASED AFTER TESTS AND ADVISED TO DRINK WATER. CUSTOMER'S BLOOD GLUCOSE READINGS WERE NOTED TO HAVE COME DOWN TO 289 MG/DL. TROUBLESHOOTING WAS PERFORMED AND THE DRIVE SUPPORT CAP AND ALL SETTINGS APPEARED TO BE NORMAL. THE HIGH PRESSURE TEST WAS PERFORMED AND PASSED. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602884 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization