BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4183056 · Received October 17, 2014

    Report

    Report Number
    2032227-2014-40007
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 19, 2014
    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. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED A HOSPITALIZATION EVENT FOR HIGH BLOOD GLUCOSE. THE CUSTOMER STATED SHE WAS HOSPITALIZED ON A TUESDAY, AT 4:00 A.M. THE CUSTOMER STATED SHE WAS VOMITING, FREQUENTLY URINATING, AND HAD HEADACHES PRIOR TO BEING HOSPITALIZED. THE CUSTOMER ALSO REPORTED BEING HOSPITALIZED BECAUSE SHE HAD DIABETES KETOACIDOSIS. SHE ALSO STATED HER HEALTHCARE PROVIDER INFORMED HER SHE HAD INSULIN FAILURE AND NOT INSULIN PUMP FAILURE, CAUSING HER TO HAVE HIGH BLOOD GLUCOSE. THE CUSTOMER'S BLOOD GLUCOSE WAS 338 MG/DL. THE CUSTOMER STATED SHE HAD BOLUSED FOR HER BLOOD GLUCOSE. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661634 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Hospitalization