BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3842386 · Received June 1, 2014

    Report

    Report Number
    2032227-2014-02662
    Event Type
    Injury
    Date Received
    June 1, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 8, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    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 INITIALLY CALLED TO FIND OUT HOW TO REVIEW HIS CARB RATIO. THE CUSTOMER REPORTED CALLING THE PARAMEDICS TO REVIVE HIM LAST WEEK. THE CUSTOMER REPORTED HE HAS BEEN HAVING LOW BLOOD GLUCOSE FOR A WEEK AND A HALF. THE CUSTOMER REPORTED THAT HE WAS WORKING OUTSIDE WHEN THE LOW OCCURED, HOWEVER WAS NOT TAKEN TO THE HOSPITAL. THE CUSTOMER'S CURRENT BLOOD GLUCOSE READING IN 134 MG/DL. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320753 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention