BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3885178 · Received June 19, 2014

    Report

    Report Number
    3004209178-2014-86057
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    May 12, 2014
    Report Date
    June 6, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT SHE WAS HOSPITALIZED TWO WEEKS AGO AND HAS BEEN EXPERIENCING HIGH BLOOD GLUCOSE READINGS. THE CUSTOMER'S BLOOD GLUCOSE READING AT THE TIME OF THE HOSPITALIZATION WAS OVER 500 MG/DL. THE CUSTOMER REPORTED SYMPTOMS OF NAUSEA AND FREQUENT URINATION. THE CUSTOMER WAS TREATED WITH INSULIN AT THE HOSPITAL. CUSTOMER ALSO REPORTED RECEIVING MOTOR ERROR ALARM ON HER INSULIN PUMP. PATIENT'S CURRENT BLOOD GLUCOSE READING IS 371. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361457 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization