BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4170992 · Received October 14, 2014

    Report

    Report Number
    2032227-2014-37938
    Event Type
    Injury
    Date Received
    October 14, 2014
    Date of Event
    September 14, 2014
    Report Date
    September 15, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    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

    IT WAS REPORTED THAT THE CUSTOMER HAD HIGH BLOOD GLUCOSE LEVELS OF 220 MG/DL. THE CUSTOMER REPORTED BEING CONFINED IN THE HOSPITAL FOR A MONTH DUE TO NON-DIABETES RELATED CAUSE. THE CUSTOMER REPORTED BEING IN A CAR ACCIDENT. THE CUSTOMER REPORTED BEING OFF THE INSULIN PUMP EVER SINCE THE CAR ACCIDENT. THE CUSTOMER REQUESTED ASSISTANCE SETTING UP THE METER OPTION ON THE INSULIN PUMP. THE METER OPTION WAS ACTIVATED ON THE INSULIN PUMP OF THE CUSTOMER. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651275 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