BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3920829 · Received July 8, 2014

    Report

    Report Number
    3004209178-2014-86628
    Event Type
    Injury
    Date Received
    July 8, 2014
    Date of Event
    October 1, 2013
    Report Date
    June 20, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    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 COMPLAINING ABOUT HER SENSORS. DURING THE CALL, SHE MENTIONED AN INCIDENT WHERE SHE WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE LEVELS. ON (B)(6) 2013, CUSTOMER STATED SHE WENT TO THE EMERGENCY ROOM AFTER SHE STARTED FEELING ILL AND HAD THE HIGHEST BLOOD GLUCOSE LEVEL SHE HAS EVER HAD. HER BLOOD GLUCOSE LEVEL AT ADMISSION WAS OVER 550 MG/DL. SHE WAS TREATED WITH IV FLUIDS AND RELEASED AFTER HER BLOOD GLUCOSE LEVEL WENT DOWN. CUSTOMER STATED THERE WERE NO SIGNIFICANT EVENTS LEADING UP TO THE INCIDENT. SHE WAS NOT IN AN ACCIDENT. CUSTOMER WAS WEARING THE DEVICE AT THE TIME OF THE EMERGENCY ROOM VISIT. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398448 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 61 YR Hospitalization