BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 8111006 · Received November 28, 2018

    Report

    Report Number
    2032227-2018-67986
    Event Type
    Injury
    Date Received
    November 28, 2018
    Date of Event
    November 16, 2018
    Report Date
    November 28, 2018
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE LEVEL OF 22.4 MMOL/L. THE CUSTOMER¿S OTHER HIGH BLOOD GLUCOSE VALUES WERE 15 MMOL/L, 18 MMOL/L, 22 MMOL/L. THE CUSTOMER TREATED HIGH BLOOD GLUCOSE VALUES USING MANUAL INJECTIONS. THE CUSTOMER EXPERIENCED HEADACHE AS A SYMPTOM OF HIGH BLOOD GLUCOSE VALUES. THE INSULIN PUMP ALSO RECEIVED MULTIPLE NO DELIVERY ALARMS. TROUBLESHOOTING WAS PERFORMED FOR NO DELIVERY ALARM AND THE ISSUE WAS RESOLVED AS INSULIN EXITED THE TUBING WITH MANUAL PRIME. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WAS WORKING AS DESIGNED. THE PRODUCT WILL NOT RETURN FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    952387 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 Other FRN-UNK-RSVRUNOMED INF SET