BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3954011 · Received July 23, 2014

    Report

    Report Number
    3004209178-2014-88122
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 24, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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. UNIT RECEIVED WITH SCRATCHED LCD WINDOW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER VISITED THE EMERGENCY ROOM FOR HIGH BLOOD GLUCOSE OF 577 MG/DL, WHICH WAS TREATED WITH IV AND MANUAL INJECTION. THE SYMPTOMS OF HIGH BLOOD GLUCOSE WERE NAUSEA AND VOMITING. AT THE EMERGENCY ROOM THE CUSTOMER HAD AN X-RAY HAD LAB WORK DONE AND WAS RELEASED. THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF THE EMERGENCY ROOM VISIT. THE CUSTOMER'S BLOOD GLUCOSE AT THE TIME OF THE PHONE CALL WAS 254 MG/DL WHICH WAS TREATED WITH THE INSULIN PUMP. THE DRIVE SUPPORT CAP WAS RECESSED. THE DEVICE PASSED ALL FUNCTIONAL TESTS, INCLUDING HIGH PRESSURE TEST. THE SETTINGS WERE CORRECT. IN THE ALARM HISTORY FOUND LOW RESERVOIR ALARM. TE CUSTOMER STATED THAT THEY ALREADY HAD THE INSULIN PUMP REPLACED 3-4 TIMES. THEY WANTED THEIR CURRENT DEVICE TO BE REPLACED AS WELL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431379 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization