BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3182751 · Received June 21, 2013

    Report

    Report Number
    2032227-2013-02515
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    May 25, 2013
    Report Date
    May 30, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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 CALLED TO REPORT A HOSPITALIZATION DUE TO HIGH BLOOD GLUCOSE. THE CURRENT BLOOD GLUCOSE READING IS 85 MG/DL. CUSTOMER EXPERIENCED DIFFICULTY BREATHING AND HIGH BLOOD GLUCOSE WOULD NOT DECREASE. DIAGNOSED DIABETIC KETOACIDOSIS. DURING TROUBLESHOOTING, TIME AND DATE ARE INCORRECT. ASSISTED WITH CORRECTING. PROGRAMMING IS CORRECT. DURING MANUAL PRIME, INSULIN DID EXIT THE TUBING. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282311 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Hospitalization