BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3261074 · Received August 2, 2013

    Report

    Report Number
    2032227-2013-03297
    Event Type
    Injury
    Date Received
    August 2, 2013
    Date of Event
    June 28, 2013
    Report Date
    July 8, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT A HOSPITALIZATION FOR HIGH BLOOD GLUCOSE. THE CURRENT BLOOD GLUCOSE READING IS 344 MG/DL. CUSTOMER EXPERIENCED NAUSEA AND VOMITING. CUSTOMER HAS TREATED FOR HIGH BLOOD GLUCOSE. THE BLOOD GLUCOSE READING AT THE TIME OF THE EVENT WAS OVER 400 MG/DL. CUSTOMER EXPERIENCED SWEATINESS AND CHILLS. DURING TROUBLESHOOTING, THE PROGRAMMING IS CORRECT. MANUAL PRIME IS CORRECT, THE INSULIN EXITS THE TUBING. THE HIGH PRESSURE TEST PASSED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362185 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization