BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2090145 · Received May 5, 2011

    Report

    Report Number
    3004209178-2011-81382
    Event Type
    Injury
    Date Received
    May 5, 2011
    Date of Event
    April 28, 2011
    Report Date
    April 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
    CA
    Reporter Occupation
    OTHER

    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS AT THE EMERGENCY ROOM WITH DIABETES KETOACIDOSIS. IT WAS STATED THAT THE CUSTOMER'S BLOOD GLUCOSE AT THE HOSPITAL WAS 26MG/DL. IT WAS STATED THAT THE CUSTOMER WAS VOMITING BEFORE GOING TO THE HOSPITAL. TROUBLESHOOTING WAS PERFORMED. THE TIME, DATE, PROGRAMMING, AND SETTINGS WERE CORRECT. IT WAS STATED THAT THE CUSTOMER WAS CONCERNED REGARDING THE CARBOHYDRATES INTAKE. IT WAS STATED THAT THE INSULIN PUMP READ 209 GRAMS AND IT IS RECORDED ONLY 90 GRAMS IN HER BOOK. HAD CUSTOMER TO DISCONNECT FROM THE QUICK RELEASE TO RUN A FIXED PRIME AND HIGH PRESSURE TESTS. THE INSULIN PUMP PASSED THE TESTS. NO FURTHER INFO 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-522CAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization