BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4033023 · Received August 25, 2014

    Report

    Report Number
    3004209178-2014-97670
    Event Type
    Injury
    Date Received
    August 25, 2014
    Date of Event
    July 20, 2014
    Report Date
    July 24, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR
    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

    IT WAS REPORTED THAT CUSTOMER WAS HOSPITALIZED FOR TWO DAYS DUE TO DIABETIC KETOACIDOSIS. CUSTOMER REPORTED THAT SHE WAS NOT GETTING ANY ALERTS OR INSULIN. CUSTOMER STATED SHE WAS HAVING A DIFFICULT TIME CONTROLLING HER SUGAR AND THAT SHE HAD GIVEN HERSELF MORE INSULIN THAN USUAL. CUSTOMER REPORTED A BLOOD GLUCOSE LEVEL OF 600 MG/DL. CUSTOMER WAS WEARING THE PUMP AT THE TIME OF EMERGENCY ROOM VISIT. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514760 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR