BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722NALL

    MDR report key: 1973857 · Received January 18, 2011

    Report

    Report Number
    3004209178-2011-80162
    Event Type
    Injury
    Date Received
    January 18, 2011
    Date of Event
    January 5, 2011
    Report Date
    January 6, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR DIABETES KETOACIDOSIS. THE NURSE STATED THAT THE CUSTOMER WAS COMPLAINING OF VOMITING AND STOMACH PAIN. IT WAS STATED THAT THE CUSTOMER WAS NOT TAKEN OFF THE DEVICE AND SHE HAS BEEN TREATING WITH THE INSULIN PUMP. TROUBLESHOOTING WAS PERFORMED. VERIFIED THE ALARM HISTORY, DAILY TOTALS, TIME, DATE, AND BASAL AND BOLUS HISTORY. THE DAILY TOTAL SHOWED AN INCREASE OF INSULIN FOR ONE DAY. REVIEWED THE PRIME HISTORY AND IT DOES NOT SHOW THE BLOOD GLUCOSE SET WAS CHANGED. RAN A FIXED PRIME TEST AND THE TEST PASSED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Hospitalization