BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3160710 · Received June 10, 2013

    Report

    Report Number
    3004209178-2013-94582
    Event Type
    Injury
    Date Received
    June 10, 2013
    Date of Event
    May 24, 2013
    Report Date
    May 24, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    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 LOW BLOOD GLUCOSE. THE NURSE STATED THAT THAT THE HISTORY WAS CHECKED AND THE SENSOR GLUCOSE VALUES WERE NOT REFLECTING THE ACTUAL BLOOD GLUCOSE READINGS. THE CALLER MENTIONED THAT THE CUSTOMER FELL AND HURT HIS HIP. THE NURSE STATED THAT THEY ARE STILL ATTEMPTING TO VERIFY IF THE CUSTOMER'S FALL WAS DUE TO HIS HEART OR DUE TO HIS LOW BLOOD GLUCOSE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260426 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization