BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4252214 · Received November 14, 2014

    Report

    Report Number
    2032227-2014-52818
    Event Type
    Injury
    Date Received
    November 14, 2014
    Date of Event
    October 19, 2014
    Report Date
    October 19, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PATIENT

    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. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTS TO HAVE EXPERIENCED LOW AND HIGH BLOOD GLUCOSE. CUSTOMER STATES HIS FRIEND WHO IS ALSO AN EMERGENCY MEDICAL TECHNICIAN GAVE HIM GLUCOSE TABLETS TO BRING BLOOD GLUCOSE BACK UP. CUSTOMER DOES NOT RECALL EXACTLY WHAT OCCURRED BUT HE BROKE HIS ANKLE IN THE EVENT. CUSTOMER HAD SURGERY TO REPAIR ANKLE. CUSTOMER STATES AFTER BEING OUT OF THE HOSPITAL, HE WAS EXPERIENCING HIGH BLOOD GLUCOSE AND WOULD LIKE TO TEST INSULIN PUMP. DURING TROUBLESHOOTING, IT WAS FOUND THAT DRIVE SUPPORT CAP APPEARED NORMAL, NO AIR FOUND IN TUBING, AND INSULIN DID EXIT THE TUBING AND THERE WERE NO LEAKS. CUSTOMER WAS ADVISED THAT INSULIN PUMP FUNCTIONED AS DESIGN AND TO CONTACT HEALTHCARE PROFESSIONAL REGARDING HIGH AND LOW BLOOD GLUCOSE. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738515 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization