BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2202379 · Received August 4, 2011

    Report

    Report Number
    2032227-2011-01943
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    July 20, 2011
    Report Date
    July 21, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS, WITH BLOOD GLUCOSE LEVELS OVER 600 MG/DL. THE CUSTOMER EXPERIENCED WEAKNESS AND AN IRREGULAR HEARTBEAT. THE CUSTOMER HAD BEEN EXPERIENCING HIGH BLOOD GLUCOSE LEVELS FOR THE PAST THREE DAYS. PRIOR TO THE HOSPITALIZATION, THE CUSTOMER TREATED HER BLOOD GLUCOSE LEVELS WITH THE INSULIN PUMP AND WITH MANUAL INJECTIONS, BUT HER BLOOD GLUCOSE REMAINED HIGH. HER BLOOD GLUCOSE LEVELS REGULATED ONCE SHE WAS ON AN INSULIN DRIP AT THE HOSPITAL. AS SOON AS SHE WAS PUT BACK ON THE INSULIN PUMP, HER BLOOD GLUCOSE LEVELS ROSE TO OVER 400 MG/DL. LATER, THE CUSTOMER'S TERRITORY MANAGER CALLED REQUESTING A REPLACEMENT INSULIN PUMP. 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-722RNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization