BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XMTR MMT-7703NA MINILINK GST1 17L REPL

    MDR report key: 1853297 · Received September 29, 2010

    Report

    Report Number
    2032227-2010-82804
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    September 10, 2010
    Report Date
    September 10, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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. WE, THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT HE HAS HAD TO CALL THE PARAMEDICS THREE TIMES OVER THE PAST TWO WEEKS DUE TO LOW BLOOD GLUCOSE LEVELS. THE CUSTOMER'S BLOOD GLUCOSE LEVELS HAVE DROPPED BELOW 30 MG/DL, BUT THE SENSOR GLUCOSE READINGS HAVE BEEN BETWEEN 65 AND 70 MG/DL. ALSO FOUND THAT THE CHARGER IS NOT FUNCTIONING PROPERLY. NOTHING FURTHER WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention