BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 2971267 · Received July 16, 2007

    Report

    Report Number
    3004209178-2007-04731
    Event Type
    Injury
    Date Received
    July 16, 2007
    Date of Event
    June 24, 2007
    Report Date
    July 2, 2007
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    OYC
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    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 THE DEVICE HAS NOT YET BEEN EVALUATED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE, CONSIDER THIS REPORT COMPETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TWO INCIDENCES OF LOW BLOOD GLUCOSE LEVELS IN ONE WEEK. ONE INCIDENT REQUIRED TREATMENT BY THE PARAMEDICS FOR BLOOD GLUCOSE LEVELS OF 32 MG/DL, AND THE OTHER REQUIRED HOSPITALIZATION FOR BLOOD GLUCOSE LEVELS OF 39 MG/DL. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-715NAS PRDGM INS V2.1 SK EN INFUSION PUMP OYC MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-715NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization