BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2082768 · Received April 28, 2011

    Report

    Report Number
    2032227-2011-01068
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    April 16, 2011
    Report Date
    April 17, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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 LEVELS OVER 500 MG/DL. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE INSULIN PUMP PASSED THE PRIME AND HIGH PRESSURE TESTS. ON THE DAY OF THE HOSPITALIZATION, THE CUSTOMER RECEIVED A NO DELIVERY ALARM. THE CUSTOMER CHANGED THE INFUSION SET, BUT NOT THE RESERVOIR. ALSO, THE CUSTOMER PROGRAMMED A BOLUS, BUT DIDN'T ENTER THE BLOOD GLUCOSE OR CARBOHYDRATE AMOUNT IN THE BOLUS WIZARD. INSTEAD, THE CUSTOMER MANUALLY INPUT A BOLUS OF 15.5 UNITS. ADVISED THE CUSTOMER TO CHANGE THE ENTIRE INFUSION SET WHEN EXPERIENCING HIGH BLOOD GLUCOSE LEVELS. 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-722RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization