BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3982341 · Received August 5, 2014

    Report

    Report Number
    3004209178-2014-90252
    Event Type
    Injury
    Date Received
    August 5, 2014
    Date of Event
    June 30, 2014
    Report Date
    July 5, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    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

    CUSTOMER'S MOTHER REPORTED THAT THEY HAD ISSUES WITH CANNULAS BEING BENT ON THEIR INFUSION SETS. SHE STATED THAT THE CUSTOMER WAS IN THE HOSPITAL DUE TO HIGH BLOOD GLUCOSE OF 560 MG/DL AND DIABETIC KETOACIDOSIS. CUSTOMER WAS TREATED WITH FLUIDS AND MANUAL INJECTIONS. AT THE TIME OF THE REPORT, THE CUSTOMER'S BLOOD GLUCOSE READING WAS 301 MG/DL. THE DRIVE SUPPORT CAP APPEARED TO BE NORMAL AND RECESSED. CUSTOMER'S MOTHER FOUND NO AIR IN THE TUBING AND NO LEAKS. SHE WAS ADVISED TO RUN A MANUAL PRIME AND STATED THAT INSULIN DID EXIT THE TUBING. THEY WERE UNABLE TO COMPLETE THE HIGH PRESSURE TEST. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458336 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 14 YR Hospitalization