BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3141116 · Received June 3, 2013

    Report

    Report Number
    3004209178-2013-94287
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    May 4, 2013
    Report Date
    May 14, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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 WITH DIABETIC GASTROPARESIS. IT WAS STATED THAT THE CUSTOMER HAD BEEN VOMITING FOR A WEEK. TROUBLESHOOTING WAS PERFORMED. THE TIME AND DATE WERE INCORRECT. ASSISTED THE CALLER TO CORRECT THEM. THE BASAL RATES WERE CORRECT. REVIEWED THE ALARM HISTORY AND FOUND A NO DELIVERY ALARM. THE DRIVE SUPPORT CAP APPEARS TO BE NORMAL. INSTRUCTED THE SPOUSE TO RUN A MANUAL PRIME TEST AND THE INSULIN DID EXIT. ADVISED THE WIFE TO CALL BACK WHEN THE TUBING CLAMP ARRIVES TO CONTINUE TESTING. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243396 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 75 YR Hospitalization