BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3831042 · Received May 23, 2014

    Report

    Report Number
    3004209178-2014-84950
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    February 2, 2013
    Report Date
    May 4, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    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 TO REPORT A HOSPITALIZATION FOR A HYPOGLYCEMIC EVENT. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS AROUND 40MG/DL AT THE TIME OF THE HOSPITALIZATION BUT THE MOST RECENT GLUCOSE LEVEL WAS 140MG/DL. THE CUSTOMER STATES THAT THE EVENTS LEADING UP TO ADMISSION WERE EXCESSIVE DRINKING. THE CUSTOMER ALSO STATES THAT HER HYPOGLYCEMIA COULD HAVE BEEN CAUSED BY TAKING TOO MUCH INSULIN BECAUSE SHE WAS UNAWARE OF WHAT TO DO WHILE DRINKING. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307986 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 40 YR Hospitalization