BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3974095 · Received August 1, 2014

    Report

    Report Number
    2032227-2014-05260
    Event Type
    Injury
    Date Received
    August 1, 2014
    Date of Event
    June 11, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    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

    THE CUSTOMER REPORTED SHE WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS. CUSTOMER'S BLOOD GLUCOSE WAS 630 MG/DL. TROUBLESHOOTING WAS PERFORMED. CUSTOMER'S SYMPTOM WAS VOMITING. CUSTOMER WAS NOT INVOLVED IN A CAR ACCIDENT. CUSTOMER WAS RELEASED AND IS WORKING WITH ENDO TO FIX THE ISSUE. THE INSULIN PUMP WAS WORN DURING HOSPITALIZATION. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450907 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523RNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization