BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2190295 · Received July 19, 2011

    Report

    Report Number
    2032227-2011-01788
    Event Type
    Injury
    Date Received
    July 19, 2011
    Date of Event
    June 20, 2011
    Report Date
    July 8, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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 DUE TO DIABETIC KETOACIDOSIS, WITH A BLOOD GLUCOSE READING OF 338 MG/DL. THE CUSTOMER WAS ALSO EXPERIENCING THIRST AND VOMITING. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE INSULIN PUMP DID NOT PASS THE PRIME TEST. THE CUSTOMER CHANGED THE INFUSION SET, AND THE INSULIN PUMP DID PASS THE SECOND PRIME TEST. THE CUSTOMER FELT THAT THE INFUSION SETS WERE THE REASON FOR THE HIGH BLOOD GLUCOSE LEVELS, AND DECLINED FURTHER TROUBLESHOOTING.

    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-722RNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization