BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3034031 · Received April 3, 2013

    Report

    Report Number
    3004209178-2013-92315
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 22, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE ,THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS IN THE EMERGENCY ROOM DUE TO DIABETES KETOACIDOSIS AND HIGH BLOOD GLUCOSE. THE CALLER STATED THAT THE CUSTOMER WAS THROWING UP AND HAVING DIARRHEA ALL DAY LONG. TROUBLESHOOTING WAS PERFORMED. THE TIME AND DATE ON THE DEVICE WERE CORRECT. THE DRIVE SUPPORT CAP APPEARS NORMAL. THE CALLER MENTIONED THAT AIR BUBBLES WERE FOUND IN THE INFUSION SET TUBING. ASSISTED THE CALLER TO RUN A MANUAL PRIME TEST AND THE INSULIN DID EXIT. ADVISED THE CALLER TO CALL BACK WHEN THE TUBING CLAMP ARRIVES TO COMPLETE TESTING. IT WAS MENTIONED THAT THE CUSTOMER CHANGES THE INFUSION SET EVERY THREE TO FOUR DAYS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137274 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization