BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3250979 · Received July 29, 2013

    Report

    Report Number
    3004209178-2013-96129
    Event Type
    Injury
    Date Received
    July 29, 2013
    Date of Event
    December 14, 2012
    Report Date
    July 20, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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.

    Description of Event or Problem · 1

    A PHONE CALL WAS CONDUCTED IN ORDER TO FOLLOW UP ON A PREVIOUS CALL THAT THE CUSTOMER MADE FOR UNEXPLAINED HIGH BLOOD GLUCOSE AND FOUND THAT THE CUSTOMER RECEIVED EMERGENCY MEDICAL ASSISTANCE DUE TO LOW BLOOD GLUCOSE. TROUBLESHOOTING WAS PERFORMED AT THAT TIME, AND APPEARED THAT THE INSULIN PUMP WAS FUNCTIONING PROPERLY. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352595 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR