BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1142779 · Received August 27, 2008

    Report

    Report Number
    2032227-2008-01486
    Event Type
    Injury
    Date Received
    August 27, 2008
    Date of Event
    August 11, 2008
    Report Date
    August 17, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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 HOSPITALIZED DUE TO HYPERGLYCEMIA. THE CUSTOMER STATED THAT HER BLOOD GLUCOSE READING WAS 800 MG/DL AND THAT SHE IN A COMA. THE CUSTOMER STATED THAT HER BLOOD GLUCOSE LEVELS HAVE BEEN FINE SINCE LEAVING THE HOSPITAL AND THAT THE INSULIN PUMP IS WORKING FINE. THE CUSTOMER STATED THAT SHE WILL CALL BACK TO PERFORM TROUBLESHOOTING.

    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