BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2823247 · Received November 7, 2012

    Report

    Report Number
    3004209178-2012-90605
    Event Type
    Injury
    Date Received
    November 7, 2012
    Date of Event
    October 4, 2012
    Report Date
    October 25, 2012
    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

    IT WAS REPORTED THAT THE PARAMEDICS WERE CALLED. THE CALLER STATED THAT CUSTOMER IS NO LONGER ON THE INSULIN PUMP BECAUSE THREE WEEKS AGO SHE RECEIVED NO DELIVERY ALARMS, AND SHE WAS HOSPITALIZED FOR FIVE DAYS DUE TO DIABETES KETOACIDOSIS AND HIGH BLOOD GLUCOSE OF 1300MG/DL. THE CUSTOMER STATED THAT SHE INJECTED HERSELF WITH INSULIN ON HER OWN, AND THEN SHE WENT TO THE HOSPITAL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Hospitalization