BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4143051 · Received September 27, 2014

    Report

    Report Number
    2032227-2014-30168
    Event Type
    Injury
    Date Received
    September 27, 2014
    Date of Event
    August 29, 2014
    Report Date
    August 29, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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'S GUARDIAN REPORTED THAT THE INSULIN PUMP ALARMED NO DELIVERY. CUSTOMER'S BLOOD GLUCOSE WAS 280 MG/DL. TROUBLESHOOTING WAS DONE. CUSTOMER'S BLOOD GLUCOSE AT THAT TIME WAS 474 MG/DL STATED TREATED HIGH BLOOD GLUCOSE WITH INSULIN PUMP. CUSTOMER CHANGED AND PUT A LOANER PUMP AND TOOK 5 UNITS AND IT WORKED BUT WHEN HE GOT HOME AND PLUG IN CARBS THEN THE NO DELIVERY CAME BACK. CUSTOMER STATED THAT THE ALARM WAS RESOLVED BY AN INFUSION SET CHANGED. CUSTOMER HAD HIGH BLOOD GLUCOSE OF 400% MG/DL AND USED A LOANER PUMP. OFFERED TO TROUBLESHOOT HIGH BLOOD GLUCOSE BUT CUSTOMER NOT HOME. ADVISED TO CALL BACK IF PROBLEM PERSISTS. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603505 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC MEDTRONIC MINIMED MMT-523RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR