BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-511LNAS PRDGM INS SK EN US LN

    MDR report key: 1052826 · Received May 27, 2008

    Report

    Report Number
    2032227-2008-00895
    Event Type
    Injury
    Date Received
    May 27, 2008
    Date of Event
    May 11, 2008
    Report Date
    May 15, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K001829
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 STATED THAT SHE WAS TREATED BY THE PARAMEDICS FOR LOW BLOOD GLUCOSE LEVELS. NO BLOOD GLUCOSE READING WAS REPORTED. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE INSULIN PUMP PASSED THE DISPLACEMENT TEST. THE CUSTOMER STATED THAT SHE HAS LOWERED HER OVERNIGHT BASAL RATE EVER SINCE THE EVENT. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-511LNAS PRDGM INS SK EN US LN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-511LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention