BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3864551 · Received June 10, 2014

    Report

    Report Number
    2032227-2014-02965
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 15, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    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 A HOSPITALIZATION DUE TO HIGH BLOOD GLUCOSE. THE CUSTOMER REPORTED VOMITING. THE CUSTOMER'S BLOOD GLUCOSE WAS 504 MG/DL AT THE TIME OF HOSPITALIZATION. DIAGNOSED DIABETES KETOACIDOSIS. HOSPITAL TREATED WITH INSULIN DRIP. THE CUSTOMER STATED THAT THE INSULIN PUMP WAS NOT GIVING HIM ENOUGH INSULIN. DURING TROUBLESHOOTING, THE CUSTOMER REINSERTED THE RESERVOIR AND PERFORMED A MANUAL PRIME, THE INSULIN DID EXIT. THE CURRENT BLOOD GLUCOSE READING IS 282 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340888 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Hospitalization