BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3973921 · Received August 1, 2014

    Report

    Report Number
    3004209178-2014-88917
    Event Type
    Injury
    Date Received
    August 1, 2014
    Date of Event
    June 26, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    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 LOST CONSCIOUSNESS DUE TO LOW BLOOD GLUCOSE AT 23 MG/DL. EMERGENCY MEDICAL SERVICES WERE DISPATCHED TO HIS HOME AND HE WAS TAKEN TO THE EMERGENCY ROOM, WHERE HIS LOW BLOOD GLUCOSE WAS TREATED WITH GLUCOSE UNTIL THE PATIENT WAS STABLE. THE CUSTOMER FELT THAT A TECHNICIAN HE HAD SPOKEN WITH PREVIOUSLY HAD GIVEN HIM INCORRECT INSTRUCTIONS THAT LED TO THIS EVENT. SPECIFICALLY, THE CUSTOMER STATED THE TECHNICIAN INSTRUCTED HIM TO CONNECT THE RESERVOIR BACK TO THE PUMP WHILE IT WAS CONNECTED TO HIS BODY, CAUSING LOW BLOOD GLUCOSE. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450981 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization