BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3233333 · Received July 18, 2013

    Report

    Report Number
    3004209178-2013-95811
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 27, 2013
    Report Date
    June 28, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    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 INCLUDING THE DISPLACEMENT TEST. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS. NO MOISTURE DAMAGE ON THE MOTOR ASSEMBLY OR ELECTRONIC ASSEMBLY NOTED DURING VISUAL INSPECTION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING HOSPITALIZED DUE TO DIABETES KETOACIDOSIS AND HIGH BLOOD GLUCOSE OVER 600MG/DL. THE CALLER STATED THAT THE DOCTOR TOLD HER NOT TO USE THE DEVICE BECAUSE THE INSULIN FROM THE RESERVOIR LEAKED INTO THE RESERVOIR COMPARTMENT, AND SHE DID NOT RECEIVE ANY INSULIN. THE CUSTOMER STATED THAT SHE BOTTOMED OUT, AND SHE WAS GIVEN PEANUT BUTTER, CRACKERS, AND JUICE TO TREAT HER GLUCOSE LEVEL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334841 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 51 YR Hospitalization