BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3133532 · Received May 29, 2013

    Report

    Report Number
    3004209178-2013-94138
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    April 30, 2013
    Report Date
    May 12, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED LOW BLOOD GLUCOSE OF 30MG/DL, AND THE PARAMEDICS WERE CALLED TWICE. THE CALLER BELIEVES THE CUSTOMER GAVE HERSELF TOO MUCH INSULIN. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER HAD CHANGED HER BASAL RATES AND SHE CONTINUES HAVING LOW BLOOD GLUCOSE. THE DRIVE SUPPORT CAP APPEARS TO BE NORMAL. THE MOTHER STATED THAT HER FRIEND WAS UNABLE TO WAKE HER UP AND THEY WERE CALLED. REVIEWED THE PROGRAMMING, AND THE RESERVOIR WAS SHOWING MORE INSULIN THAT WHAT IS SHOWN ON THE STATUS SCREEN. PERFORMED A DISPLACEMENT TEST AND PASSED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235577 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Required Intervention