BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3801106 · Received May 8, 2014

    Report

    Report Number
    3004209178-2014-84512
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    April 23, 2014
    Report Date
    April 23, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    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 HAS HIGH BLOOD GLUCOSE. CUSTOMER HAS CHANGED THE INFUSION SET AND RESERVOIR. THE BLOOD GLUCOSE READING WAS 527 MG/DL. CUSTOMER TREATED WITH MANUAL INJECTION; NOW THE BLOOD GLUCOSE READING IS 514 MG/DL. CUSTOMER EXPERIENCING FREQUENT URINATION, NAUSEA AND HEADACHE. DURING TROUBLESHOOTING, THE 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
    277208 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR