BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1932904 · Received December 14, 2010

    Report

    Report Number
    2032227-2010-83437
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    November 16, 2010
    Report Date
    November 30, 2010
    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 REPORTED BEING HOSPITALIZED FOR HIGH BLOOD GLUCOSE OF 500MG/DL. THE CUSTOMER ALSO REPORTED THAT HE WAS ADMITTED IN THE HOSPITAL FOR HYPOGLYCEMIA ON (B)(6), 2010. THE CUSTOMER STATED THAT HE WAS TREATED WITH MANUAL INJECTIONS, AND HE WAS SENT HOME. THE CUSTOMER STATED THAT HE IS ON DIALYSES, AND HE REUSES THE RESERVOIRS. EXPLAINED THE CUSTOMER THE CORRECT USAGE OF THE RESERVOIRS AND INFUSION SETS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization