BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-723NAS PRDGM INSULIN SMOKE EN

    MDR report key: 1841122 · Received September 16, 2010

    Report

    Report Number
    3004209178-2010-82823
    Event Type
    Injury
    Date Received
    September 16, 2010
    Date of Event
    August 27, 2010
    Report Date
    August 30, 2010
    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 CALLED FOR INFO ON THE BASAL RATES, CARBOHYDRATES RATIOS, AND SENSITIVITY. TROUBLESHOOTING WAS NOT PERFORMED BECAUSE THE CUSTOMER WAS NOT ON THE INSULIN PUMP WHEN ADMITTED TO THE HOSPITAL. THE CUSTOMER WAS TREATED WITH AN INSULIN INJECTION AND DRIP. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-723NAS PRDGM INSULIN SMOKE EN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization