BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-508LGB EA INSULIN BL DE LN

    MDR report key: 1080478 · Received July 21, 2008

    Report

    Report Number
    2032227-2008-01267
    Event Type
    Injury
    Date Received
    July 21, 2008
    Date of Event
    July 11, 2008
    Report Date
    July 15, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K990801
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, 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 WAS HOSPITALIZED DUE TO HYPERGLYCEMIA. THE REPORTED BLOOD GLUCOSE READING WAS 500 MG/DL. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP PASSED THE LEAD SCREW AND SELF TESTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-508LGB EA INSULIN BL DE LN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-508LGB

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization