BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3192803 · Received June 27, 2013

    Report

    Report Number
    3004209178-2013-95104
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 8, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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 DUE TO HIGH BLOOD GLUCOSE. CUSTOMER'S BLOOD GLUCOSE READING IS 400 MG/DL. CUSTOMER EXPERIENCING NAUSEA, VOMITING, ADDOMINAL PAIN, KEYTONES AND A METALLIC TASTE IN MOUTH. CUSTOMER WAS TREATED WITH INSULIN DRIP AND INJECTIONS. DIAGNOSED DIABETIC KETOACIDOSIS. DURING TROUBLESHOOTING, MANUAL PRIME IS CORRECT, INSULIN EXITED THE TUBING. HIGH PRESSURE TEST FAILED TWICE. THE INSULIN PUMP WILL BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293918 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Hospitalization