BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-723NAS PRDGM INSULIN SMOKE EN

    MDR report key: 1843436 · Received September 21, 2010

    Report

    Report Number
    3004209178-2010-82868
    Event Type
    Injury
    Date Received
    September 21, 2010
    Date of Event
    March 3, 2010
    Report Date
    September 6, 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 UNK 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 HIGH BLOOD GLUCOSE, DIABETES KETOACIDOSIS, AND INFECTION. THE BLOOD GLUCOSE READING WAS 613MG/DL. TROUBLESHOOTING WAS PERFORMED. REVIEWED INSULIN CONCENTRATION, TIME, BASALS, DAILY TOTALS, BOLUS HISTORY, AND ALARM HISTORY, ALL APPEARED TO BE CORRECT. RAN A FIXED PRIME AND HIGH PRESSURE TEST AND THE DEVICE PASSED THE TESTS. NO FURTHER INFORMATION 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 33 YR Hospitalization