BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3251011 · Received July 29, 2013

    Report

    Report Number
    3004209178-2013-96122
    Event Type
    Injury
    Date Received
    July 29, 2013
    Date of Event
    June 1, 2012
    Report Date
    July 23, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC
    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.

    Description of Event or Problem · 1

    A PHONE CALL WAS CONDUCTED IN ORDER TO FOLLOW UP ON A PREVIOUS CALL THAT THE CUSTOMER MADE FOR UNEXPLAINED HIGH BLOOD GLUCOSE AND FOUND THAT SHE WAS IN THE EMERGENCY ROOM WITH UNEXPLAINED LOW BLOOD SUGARS. THE CUSTOMER MOST RECENT GLUCOSE READING WAS 72MG/DL. INITIALLY, THE CUSTOMER REPORTED HAVING LOW BLOOD GLUCOSE. TROUBLESHOOTING WAS PERFORMED, AND THE PROGRAMMING SHOWS THAT THE CUSTOMER MADE MANUAL CHANGES TO THE BASAL TO CORRECT HER BLOOD GLUCOSE. THE RESERVOIR SHOWS THE SAME AMOUNT OF INSULIN THAT THE STATUS SCREEN SHOWS. THE DISPLACEMENT TEST WAS PERFORMED AND PASSED. THE CUSTOMER DID NOT FEEL COMFORTABLE WITH THE DEVICE AND REQUESTED A REPLACEMENT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351790 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 25 YR Hospitalization