BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2070208 · Received April 18, 2011

    Report

    Report Number
    2032227-2011-00945
    Event Type
    Injury
    Date Received
    April 18, 2011
    Date of Event
    March 25, 2011
    Report Date
    April 4, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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

    THE CUSTOMER REPORTED A SEVERE HYPOGLYCEMIC EPISODE. THE CUSTOMER STATED THAT THE POLICE AND PARAMEDICS BROKE INTO HER HOME AND FOUND HER UNCONSCIOUS, WITH BLOOD GLUCOSE LEVELS TOO LOW TO REGISTER. THE CUSTOMER WAS TAKEN TO HE EMERGENCY ROOM WHERE SHE WAS TREATED, THEN RELEASED THREE HOURS LATER. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE RESERVOIR VOLUME AND DAILY TOTALS WERE ALL CORRECT. FUND THAT THE CUSTOMER WAS RE-USING THE RESERVOIRS. ADVISED THE CUSTOMER TO ALWAYS CHANGE THE ENTIRE INFUSION SET EVERY TWO TO THREE DAYS. 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-722LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention