BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3895474 · Received June 25, 2014

    Report

    Report Number
    3004209178-2014-86127
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    May 12, 2014
    Report Date
    June 2, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    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 STATED THAT THE INSULIN PUMP IS VIBRATING AND HE CANNOT TURN IT OFF. THE INULIN PUMP IS VIBRATING EVERY 20 TO 30 MINUTES. DURING TROUBLESHOOTING, THE ALARM CLOCK WAS PROGRAMMED. THE CUSTOMER TURNED OFF THE ALARM CLOCK. CUSTOMER REPORTED A HOSPITALIZATION DUE TO HIGH BLOOD GLUCOSE. THE BLOOD GLUCOSE READING AT THE TIME OF THE EVENT WAS 400 MG/DL. CUSTOMER WAS VOMITING AND LOSS OF APPETITE. DIAGNOSED DIABETES KETOACIDOSIS. CUSTOMER WAS TREATED AND RELEASED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369879 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Hospitalization