BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722LNAB PRDGM INS BL EN ML

    MDR report key: 1780989 · Received July 27, 2010

    Report

    Report Number
    2032227-2010-82034
    Event Type
    Injury
    Date Received
    July 27, 2010
    Date of Event
    July 5, 2010
    Report Date
    July 6, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 STATED THAT THE CUSTOMER WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS, WITH A BLOOD GLUCOSE READING OF 370 MG/DL AND VOMITING. TROUBLESHOOTING WAS PERFORMED, AND THE BASAL RATES WERE PROGRAMMED, BUT THE NURSE DIDN'T KNOW IF THEY WERE CORRECT. THE INSULIN PUMP PASSED THE PRIME AND HIGH PRESSURE TESTS. AFTER REVIEWING THE BOLUS HISTORY, FOUND THAT THE CUSTOMER HAD NOT DELIVERED ANY BOLUSES FOR SIX DAYS PRIOR TO BEING HOSPITALIZED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722LNAB PRDGM INS BL EN ML INFUSION PUMP MDS MEDTRONIC MINIMED MMT-722LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Hospitalization