BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2090083 · Received May 5, 2011

    Report

    Report Number
    2032227-2011-01178
    Event Type
    Injury
    Date Received
    May 5, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 1, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    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 HOSPITAL WITH HIGH BLOOD GLUCOSE LEVELS AND VOMITING. THE REPORTED BLOOD GLUCOSE READING AT THE TIME OF THE CALL WAS 277 MG/DL. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP PASSED THE PRIME TEST. THE CUSTOMER COULD NOT CONDUCT FURTHER TROUBLESHOOTING AT THE TIME OF THE CALL. ADVISED THE NURSE TO HAVE THE CUSTOMER CALL BACK FOR FURTHER TROUBLESHOOTING ONCE HE WAS FEELING BETTER. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC MINIMED MMT-722NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Hospitalization