BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-512LNAP PRDGM INS PL EN US LN

    MDR report key: 1180054 · Received September 26, 2008

    Report

    Report Number
    2032227-2008-01671
    Event Type
    Injury
    Date Received
    September 26, 2008
    Date of Event
    August 30, 2008
    Report Date
    September 16, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K030531
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, 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

    IT WAS REPORTED THAT THE CUSTOMER HAD SEIZURES A FEW MONTHS AGO AND SINCE THEN HER GLUCOSE LEVEL STARTED TO DROP DRASTICALLY. THE CUSTOMER STATED THAT HER SUGAR LEVEL WAS TREATED WITH GLUCAGON. THE MOTHER STATED THAT THE CUSTOMER'S GLUCOSE LEVEL WAS 60MG/DL. THE CUSTOMER WAS INCOHERENT AND THE PARAMEDICS WERE CALLED AND TOOK THE CUSTOMER TO THE HOSPITAL. NO FURTHER INFORMATION WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization