BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XMTR MMT-7703NA MINILINK GST1 17L REPL

    MDR report key: 2142409 · Received June 21, 2011

    Report

    Report Number
    2032227-2011-01544
    Event Type
    Injury
    Date Received
    June 21, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 9, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A PROBLEM WITH THE TRANSMITTER NOT FLASHING OR BLINKING. THE CUSTOMER THEN STATED THAT SHE WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE LEVELS DUE TO ISSUES WITH HER LIVER. TROUBLESHOOTING WAS PERFORMED, BUT THE ISSUES WERE NO RESOLVED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XMTR MMT-7703NA MINILINK GST1 17L REPL MINILINK (PRODUCT CODE MDS) MDS MEDTRONIC MINIMED MMT-7703NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization