BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INFUSION PUMP

    MDR report key: 2062696 · Received April 12, 2011

    Report

    Report Number
    2032227-2011-00914
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 1, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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

    THE CUSTOMER WAS CALLING FROM THE HOSP WITH A BLOOD GLUCOSE READING OF 509 MG/DL. THE CUSTOMER WAS UNABLE TO TROUBLESHOOT DUE TO NOT FEELING WELL FROM THE ELEVATED BLOOD GLUCOSE LEVELS. THE CUSTOMER WAS INITIALLY TAKEN TO THE HOSP FOR TROUBLESHOOTING. ADVISED THE CUSTOMER TO CALL BACK FOR TROUBLESHOOTING ONCE SHE WAS FEELING BETTER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization