BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 8645200 · Received May 28, 2019

    Report

    Report Number
    2032227-2019-08048
    Event Type
    Injury
    Date Received
    May 28, 2019
    Date of Event
    May 14, 2019
    Report Date
    May 28, 2019
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    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

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED LOW BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 40 MG/DL. THE CUSTOMER MENTIONED OTHER BLOOD GLUCOSE VALUES AS 65 MG/DL, 318 MG/DL. THE SENSOR GLUCOSE VALUES PROVIDED BY CUSTOMER WAS 283 MG/DL, 239 MG/DL, 40 MG/DL, 74 MG/DL. THE CUSTOMER HAD ISSUE WITH CALIBRATION. THE CUSTOMER DID NOT PROVIDE INFORMATION ABOUT SYMPTOMS OF LOW BLOOD GLUCOSE VALUE. THE CUSTOMER TREATED LOW BLOOD GLUCOSE WITH FOOD. CUSTOMER REPORTED AUTO MODE WAS AUTOMATICALLY DELIVERING INSULIN AT THE TIME OF LOW BLOOD GLUCOSE EVENT. CUSTOMER USES AUTO MODE. CUSTOMER HAS BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED LOW BLOOD GLUCOSE EVENT. BASED ON CUSTOMER¿S REPORT CUSTOMER DID NOT ALLEGE OVER DELIVERY BECAUSE THEY SAW MICRO BOLUSES. THE CUSTOMER WAS NEITHER IN THE EMERGENCY ROOM, NOR ADMITTED INTO HOSPITAL AS A RESULT OF LOW BLOOD GLUCOSE. THE CUSTOMER DECLINED FURTHER TROUBLESHOOTING FOR LOW BLOOD GLUCOSE AS THEY FEELS IT WAS NOT THE INFUSION SETS AND OR RESERVOIRS BUT FEELS IT WAS AN ISSUE WITH AUTO MODE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS. THE RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439477 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 50 YR Other UNOMED INF SET, OZP-MMT-7020