BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2142396 · Received June 21, 2011

    Report

    Report Number
    2032227-2011-01525
    Event Type
    Injury
    Date Received
    June 21, 2011
    Date of Event
    April 24, 2011
    Report Date
    June 6, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 REPORTED THAT SHE WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS ON (B)(6) 2011. THE CUSTOMER'S BLOOD GLUCOSE LEVELS WERE BETWEEN 540 AND 580 MG/DL. THE CUSTOMER EXPERIENCED KETONES, CHEST PAIN, EXCESSIVE THIRST AND URINATION. THE CUSTOMER ALSO REPORTED BEING HOSPITALIZED FOR LOW BLOOD GLUCOSE LEVELS ON (B)(6) 2011. THE CUSTOMER'S BLOOD GLUCOSE LEVELS WERE BETWEEN 45 AND 48 MG/DL. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE RESERVOIR VOLUME WAS CORRECT. THE INSULIN PUMP WAS NOT EXPOSED TO A HIGH MAGNETIC FIELD. THE INSULIN PUMP PASSED THE PRIME AND HIGH PRESSURE TESTS. 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-722LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Hospitalization