BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-715LNAS PRDGM INS V2.1 SK EN

    MDR report key: 1111039 · Received August 12, 2008

    Report

    Report Number
    2032227-2008-01380
    Event Type
    Injury
    Date Received
    August 12, 2008
    Date of Event
    July 31, 2008
    Report Date
    July 31, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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'S MOTHER REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO HYPERGLYCEMIA. THE REPORTED BLOOD GLUCOSE READING WAS 364 MG/DL. THE CUSTOMER WAS NOT PRESENT AT THE TIME OF THE PHONE CALL TO PERFORM TROUBLESHOOTING. THE CUSTOMER'S MOTHER WAS ADVISED TO HAVE THE CUSTOMER CALL BACK TO PERFORM TROUBLESHOOTING. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-715LNAS PRDGM INS V2.1 SK EN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-715LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization