BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-512LNAS PRDGM INS SK EN US LN

    MDR report key: 1252820 · Received December 4, 2008

    Report

    Report Number
    2032227-2008-02016
    Event Type
    Injury
    Date Received
    December 4, 2008
    Date of Event
    April 30, 2007
    Report Date
    May 5, 2007
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K030531
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 STATED THAT PARAMEDICS WERE CALLED, BECAUSE SHE WAS SUFFERING FROM HYPOGLYCEMIA. THE REPORTED BLOOD GLUCOSE READING WAS 73 MG/DL. THE CUSTOMER STATED THAT HER HUSBAND TREATED HER WITH GLUCAGON. TROUBLESHOOTING WAS PERFORMED, AND FOUND THAT THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE DISPLACEMENT TEST PASSED. THE CUSTOMER DECLINED TO HAVE THE INSULIN PUMP REPLACED. 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 42 YR Required Intervention