BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1190056 · Received October 6, 2008

    Report

    Report Number
    2032227-2008-01736
    Event Type
    Injury
    Date Received
    October 6, 2008
    Date of Event
    September 20, 2008
    Report Date
    September 27, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING HOSPITALIZED FOR SEVERE DIABETES KETOACIDOSIS. NO BLOOD GLUCOSE LEVEL WAS PROVIDED AT THE TIME OF THE CALL. THE CUSTOMER REFUSED TO PERFORM TROUBLESHOOTING. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization