BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-515LNAL PRDGM INS V2.1 CL EN

    MDR report key: 1063308 · Received June 19, 2008

    Report

    Report Number
    2032227-2008-01023
    Event Type
    Injury
    Date Received
    June 19, 2008
    Date of Event
    June 6, 2008
    Report Date
    June 6, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 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 REPORTED BEING HOSPITALIZED FOR HYPERGLYCEMIA AND KETONES. IT WAS REPORTED THAT THE CUSTOMER FEEL ILL AND HER BLOOD GLUCOSE READING WAS 300MG/DL. THE CUSTOMER TREATED HER GLUCOSE LEVEL. THEN SHE CHECKED HER BLOOD GLUCOSE AND WENT UP TO 400MG/DL. CUSTOMER BOLUSED AND BLOOD GLUCOSE CAME DOWN. TROUBLESHOOTING WAS PERFORMED. THE PROGRAMMING IN THE DEVICE WAS CORRECT AND PASSED THE DELIVERY AND HIGH-PRESSURE TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-515LNAL PRDGM INS V2.1 CL EN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-515LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization