BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3192814 · Received June 27, 2013

    Report

    Report Number
    3004209178-2013-95115
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 9, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR
    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

    CUSTOMER CALLED REGARDING MOTOR ERROR ALARMS. THE CURRENT BLOOD GLUCOSE READING IS 121 MG/DL. THE CUSTOMER STATED THAT THERE WAS A HOSPITALIZATION DUE TO HIGH BLOOD GLUCOSE. THE BLOOD GLUCOSE READING AT THE TIME OF THE EVENT WAS 1100 MG/DL. CUSTOMER EXPERIENCE NAUSEA. DIAGNOSED WITH DIABETIC KETOACIDOSIS AND SEPSIS. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291656 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 58 YR Hospitalization