BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-511LNAB PRDGM INS BL EN US LN

    MDR report key: 1063309 · Received June 19, 2008

    Report

    Report Number
    2032227-2008-01022
    Event Type
    Injury
    Date Received
    June 19, 2008
    Date of Event
    June 6, 2008
    Report Date
    June 6, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K001829
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MANY 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 REPORTED BEING HOSPITALIZED FOR HIGH BLOOD GLUCOSE. THE BLOOD GLUCOSE READING WAS 752MG/DL. THE CUSTOMER REPORTED BEING DEHYDRATED, NAUSEATED, AND VOMITING PRIOR GOING TO THE HOSPITAL. THE CUSTOMER ALSO STATED THAT THE INSULIN PUMP ALARMED FAILED BATTERY AND SHE WAS NOT ABLE TO REMOVE THE BATTERY CAP. TROUBLESHOOTING WAS PERFORMED. THE PROGRAMMING IN THE DEVICE WAS ACCURATE. RAN A FIXED PRIME TEST AND THE INSULIN EXITED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization