BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-512LNAS PRDGM INS SK EN US LN

    MDR report key: 1211712 · Received October 23, 2008

    Report

    Report Number
    2032227-2008-01840
    Event Type
    Injury
    Date Received
    October 23, 2008
    Date of Event
    October 12, 2008
    Report Date
    October 14, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K030531
    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 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'S WIFE STATED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO DEHYDRATION AND DIABETIC KETOACIDOSIS. THE REPORTED BLOOD GLUCOSE READING AT THE TIME OF THE EVENT WAS 1053 MG/DL. AT THE TIME OF THE PHONE CALL, THE INSULIN PUMP WAS ALARMING EMPTY RESERVOIR AND OFF NO POWER. THE CUSTOMER'S WIFE REMOVED THE BATTERY FROM THE INSULIN PUMP. THE CUSTOMER'S WIFE LATER CALLED BACK FOR ASSISTANCE REPROGRAMMING THE INSULIN PUMP. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-512LNAS PRDGM INS SK EN US LN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-512LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization