BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-712RNAL PRDGM INS CL EN US RC

    MDR report key: 1063310 · Received June 19, 2008

    Report

    Report Number
    2032227-2008-01021
    Event Type
    Injury
    Date Received
    June 19, 2008
    Date of Event
    June 5, 2008
    Report Date
    June 5, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K031390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    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 REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE. REQUESTED TO HAVE A CONFERENCE CALL WITH NURSE FROM THE HOSPITAL, AND IT WAS REPORTED THAT THE CUSTOMER IS IN A COMA. THE BLOOD GLUCOSE READING WAS 1200MG/DL. IT WAS REPORTED THAT THE INSULIN PUMP WAS BEEPING AND THE CUSTOMER'S BROTHER WANTED TO KNOW HOW TO TURN OFF THE DEVICE. ADVISED BROTHER TO REMOVE THE BATTERY. THE BROTHER CALLED BACK AND ASSISTED HIM ON CLEARING THE ALARMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-712RNAL PRDGM INS CL EN US RC INFUSION PUMP LZG MEDTRONIC MINIMED MMT-712RNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization