BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-512NAB PRDGM INSULIN BL EN

    MDR report key: 1133260 · Received August 21, 2008

    Report

    Report Number
    2032227-2008-01421
    Event Type
    Injury
    Date Received
    August 21, 2008
    Date of Event
    August 10, 2008
    Report Date
    August 10, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K030531
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 HYPOGLYCEMIA. IT WAS ALSO REPORTED THAT THE CUSTOMER HAD RECEIVED AN AUTO OFF ALARM ON THE INSULIN PUMP. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-512NAB PRDGM INSULIN BL EN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-512NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization