BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3111147 · Received May 14, 2013

    Report

    Report Number
    3004209178-2013-93407
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    April 18, 2013
    Report Date
    April 18, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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

    IT WAS REPORTED BY CUSTOMER'S SPOUSE THAT THERE WAS A HOSPITALIZATION DUE TO LOW BLOOD GLUCOSE. THE CUSTOMER WAS EXPERIENCING LOW BLOOD GLUCOSE FOR FOUR MONTHS. CUSTOMER'S BLOOD GLUCOSE IS 40 MG/DL. CUSTOMER HAS TREATED WITH WITH FOOD. CUSTOMER WAS HOSPITALIZED WITH A BLOOD GLUCOSE READING OF 150 MG/DL. DURING TROUBLESHOOTING, ALL PROGRAMMING IS CORRECT. DISPLACEMENT TEST PASSED. ADVISED THAT INSULIN PUMP WILL BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213066 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Hospitalization