BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3160729 · Received June 10, 2013

    Report

    Report Number
    3004209178-2013-94608
    Event Type
    Injury
    Date Received
    June 10, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 27, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    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 INCLUDING THE DISPLACEMENT TEST. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO DIABETES KETOACIDOSIS AND HIGH BLOOD GLUCOSE WAS 757MG/DL. IT WAS STATED THAT THE CUSTOMER WAS TREATED WITH FLUIDS, BLOOD, MAGNESIUM, AND POTASSIUM. THE CUSTOMER EXPERIENCED NAUSEA, VOMITING, DIARRHEA, DIZZINESS, AND EXCESSIVE THIRST. THE CALLER MENTIONED THAT THE TIME AND DATE WERE CORRECT. THE HIGH PRESSURE TEST WAS PERFORMED AND FAILED. FURTHER TROUBLESHOOTING COULD NOT BE PERFORMED AS CUSTOMER DID NOT FEEL WELL TO CONTINUE TESTING. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261147 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 71 YR Hospitalization