BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722RNAS

    MDR report key: 1962806 · Received January 11, 2011

    Report

    Report Number
    2032227-2011-00106
    Event Type
    Injury
    Date Received
    January 11, 2011
    Date of Event
    December 23, 2010
    Report Date
    January 1, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    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 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 TREATED BY THE PARAMEDICS DUE TO A LOW BLOOD GLUCOSE READING 42 MG/DL. PRIOR TO THE EVENT THE CUSTOMER'S BASAL RATES HAD BEEN CHANGED FROM 0.10 TO 0.50, WHICH MAY HAVE CAUSED THE EVENT. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED WITH THE CORRECT TIME AND DATE. REVIEWED THE BASAL RATES, BUT THE WIFE DIDN'T KNOW WHAT THE RATES SHOULD BE. ALSO REVIEWED THE BOLUS HISTORY AND FOUND SOME DAYS WITH NO BOLUS DELIVERIES. ADVISED THAT THE TERRITORY MGR WOULD BE CONTACTED AS THE CUSTOMER MAY REQUIRE FURTHER TRAINING. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722RNAS INSULIN INFUSION PUMP MDS MEDTRONIC MINIMED MMT-722RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention