BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-712LNAS PRDGM INS SK EN US LN

    MDR report key: 1231877 · Received November 12, 2008

    Report

    Report Number
    2032227-2008-01943
    Event Type
    Injury
    Date Received
    November 12, 2008
    Date of Event
    October 31, 2008
    Report Date
    November 1, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K031390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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'S FATHER REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO HYPOGLYCEMIA. THE CUSTOMER'S FATHER STATED THAT THE CUSTOMER WAS INCOHERENT AND MAY HAVE HAD A SEIZURE PRIOR TO BEING TAKEN TO THE HOSPITAL. THE CUSTOMER'S FATHER STATED THAT WHEN HE FOUND THE CUSTOMER THE INSULIN PUMP HAD ALARMED AND THERE WERE LINES ACROSS THE DISPLAY. TROUBLESHOOTING WAS PERFORMED AND FOUND THAT THE SETTINGS ON THE INSULIN PUMP HAD BEEN ERASED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-712LNAS PRDGM INS SK EN US LN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-712LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization