BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-511LNAS PRDGM INS SK EN US LN

    MDR report key: 1103217 · Received August 8, 2008

    Report

    Report Number
    2032227-2008-01362
    Event Type
    Injury
    Date Received
    August 8, 2008
    Date of Event
    July 25, 2008
    Report Date
    July 28, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K001829
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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

    THE CUSTOMER STATED THAT SHE WAS HOSPITALIZED DUE TO HYPOGLYCEMIA. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE CUSTOMER STATED THAT HER BLOOD GLUCOSE LEVELS HAVE BEEN LOW IN THE EARLY MORNING. THE CUSTOMER STATED THAT SHE HAS BEEN EXERCISING AND LOSING WEIGHT. THE CUSTOMER STATED THAT SHE HAS ATTEMPTED TO LOWER HER BASAL RATES, BUT THE LOW BLOOD GLUCOSE LEVELS HAVE PERSISTED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-511LNAS PRDGM INS SK EN US LN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-511LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization