BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINILINK TRANSMITTER

    MDR report key: 2962328 · Received February 14, 2013

    Report

    Report Number
    2032227-2013-00615
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    January 25, 2013
    Report Date
    January 25, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE FAILED TO TRANSMIT DUE TO DAMAGED COW CATCHER CORNERS AND A DAMAGED CONTACT PIN. PLEASE SEE ALSO MFR REPORT NUMBER 2032227-2013-00626.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HE WAS TREATED BY HE PARAMEDICS DUE TO A LOW BLOOD GLUCOSE READING OF 50 MG/DL. THE CUSTOMER STATED THAT HIS BLOOD GLUCOSE LEVELS WERE BELOW 40 MG/DL BEFORE THE PARAMEDICS ARRIVED. THE CUSTOMER ALSO REPORTED HAVING PROBLEMS WITH THE SENSOR GLUCOSE AND BLOOD GLUCOSE READINGS. THE CUSTOMER REQUESTED A REPLACEMENT TRANSMITTER. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65326 MINILINK TRANSMITTER CGM MDS MEDTRONIC MINIMED MMT-7703NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention