BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3954001 · Received July 23, 2014

    Report

    Report Number
    3004209178-2014-88120
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    May 3, 2013
    Report Date
    June 24, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 REPORTED HOSPITALIZATION DUE TO HIGH BLOOD GLUCOSE READINGS OF AROUND 500 MG/DL. CUSTOMER REPORTED SYMPTOMS OF FEELING NAUSEATED AND THROWING UP PRIOR TO THE HOSPITALIZATION. CUSTOMER USED THE BOLUS WIZARD TO BRING HER BLOOD GLUCOSE LEVELS DOWN, HOWEVER HER BLOOD GLUCOSE LEVELS CONTINUED TO INCREASE AND SHE WAS TAKEN TO THE HOSPITAL. CUSTOMER WAS TREATED WITH IV DRIPS AT THE HOSPITAL. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432163 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Hospitalization