BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-515NAS PRDGM INS V2. 1 SK EN

    MDR report key: 1052822 · Received May 27, 2008

    Report

    Report Number
    3004209178-2008-00366
    Event Type
    Injury
    Date Received
    May 27, 2008
    Date of Event
    May 14, 2008
    Report Date
    May 14, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    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

    IT WAS STATED THAT THE CUSTOMER WAS HOSPITALIZED FOR HIGH GLUCOSE LEVELS. THE DIABETES EDUCATOR REPORTED A BLOOD GLUCOSE READING OF 471 MG/DL. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE INSULIN PUMP PASSED THE PRIME, HIGH PRESSURE AN SELF TESTS. ADVISED THE DIABETES EDUCATOR ON HAVING THE CUSTOMER USE DIFFERENT INFUSION SETS AND INSERTING IN DIFFERENT AREAS OF THE BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-515NAS PRDGM INS V2. 1 SK EN INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-515NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization