BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3112610 · Received May 14, 2013

    Report

    Report Number
    3004209178-2013-93486
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    April 21, 2013
    Report Date
    April 21, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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 INSULIN PUMP IS OVER DELIVERING INSULIN. THE CUSTOMER HAS BEEN EXPERIENCING LOW BLOOD GLUCOSE. THE CURRENT BLOOD GLUCOSE READING IS 78 MG/DL. CUSTOMER HAS TREATED WITH FOOD. CUSTOMER STATED THAT THE INSULIN PUMP IS DELIVERING INSULIN EVERY FIVE MINUTES. CUSTOMER STATED THAT SHE WAS MENTALLY CONFUSED AND FEELING LIGHTHEADED. DURING TROUBLESHOOTING, THE PROGRAMMING IS CORRECT. THE STATUS SCREEN AND RESERVOIR ARE SHOWING THE SAME AMOUNTS OF INSULIN. CUSTOMER'S BLOOD GLUCOSE LEVEL ROSE TO 132 MG/DL BEFORE SHE DISCONNECTED THE CALL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212645 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR