BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 1993482 · Received February 8, 2011

    Report

    Report Number
    3004209178-2011-80358
    Event Type
    Injury
    Date Received
    February 8, 2011
    Date of Event
    March 1, 2010
    Report Date
    January 28, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S INSULIN PUMP ALARMED BUTTON ERROR FOR ABOUT TWO WEEKS. TROUBLESHOOTING WAS PERFORMED. THE MOTHER STATED THAT THE CUSTOMER WAS HOSPITALIZED FOUR TIMES FOR DIFFERENT REASONS. THE MOTHER STATED THAT IN MARCH, THE CUSTOMER WAS ADMITTED IN THE HOSPITAL AND THEY REALIZED THE CANNULA WAS BENT. IT WAS STATED THAT THE CUSTOMER AGAIN WAS HOSPITALIZED FOR DIABETES KETOACIDOSIS IN JULY. THE MOTHER STATED THAT THE CUSTOMER HAD HIGH BLOOD GLUCOSE OVER 500MG/DL. THE CUSTOMER ATTEMPTED TO BOLUS, BUT HIS GLUCOSE LEVEL CONTINUED TO RISE. THE MOTHER STATED THAT THE CUSTOMER ALSO WAS HOSPITALIZED IN OCTOBER AND IN DECEMBER. IT WAS STATED THAT THE CUSTOMER BECAME ILL DUE TO ADRENAL INSUFFICIENCY AND UNCONTROLLABLE HIGH BLOOD GLUCOSE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Hospitalization