BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4212455 · Received October 25, 2014

    Report

    Report Number
    2032227-2014-42573
    Event Type
    Injury
    Date Received
    October 25, 2014
    Date of Event
    September 26, 2014
    Report Date
    September 26, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    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

    CUSTOMER REPORTED EXPERIENCING HIGH BLOOD GLUCOSE READINGS. CUSTOMER STATED THAT THEY WOKE UP WITH BLOOD GLUCOSE READINGS OF 248 MG/DL AND TWO HOURS AFTER A MEAL THEY WERE 459 MG/DL. CUSTOMER TOOK 5 UNITS OF INSULIN WITH THE INSULIN PUMP AND THE BLOOD GLUCOSE READINGS ARE NOW 477 MG/DL. CUSTOMER REPORTED SYMPTOMS OF NAUSEA AND HEADACHE. TROUBLESHOOTING WAS PERFORMED AND THE DRIVE SUPPORT CAP AND ALL SETTINGS APPEARED TO BE NORMAL. THE HIGH PRESSURE TEST WAS PERFORMED AND PASSED. THE CANNULA WAS NOTED TO BE BENT. CUSTOMER STATED THAT THEY HAVE TREATED WITH A SYRINGE AND THE BLOOD GLUCOSE READINGS AT THE END OF THE CALL WERE 430 MG/DL. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680683 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC MEDTRONIC MINIMED MMT-723RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR