BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2090165 · Received May 5, 2011

    Report

    Report Number
    3004209178-2011-81375
    Event Type
    Injury
    Date Received
    May 5, 2011
    Date of Event
    April 26, 2011
    Report Date
    April 26, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    NOT APPLICABLE

    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 HOSPITALIZED FOR HIGH BLOOD GLUCOSE OF 21MMOL/L AND KETONES. IT WAS STATED THAT THE INSULIN PUMP DELIVERED INSULIN PROPERLY, BUT THE CUSTOMER'S BLOOD GLUCOSE WENT ABOVE NORMAL WITHIN A DAY. TROUBLESHOOTING WAS PERFORMED. THE DAILY TOTALS WERE COMPARED WITH THE BASALS AND BOLUSES DELIVERED. DIFFERENCES WERE FOUND BETWEEN THE UNITS IN THE HISTORY. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-722WWP

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization