BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINILINK TRANSMITTER

    MDR report key: 3954184 · Received July 23, 2014

    Report

    Report Number
    2032227-2014-04661
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 25, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    TRANSMITTER WAS RECEIVED WITH ISIG VALUE OUT OF RANGE DUE TO CONTAMINATION ON ALL CONTACT PINS AND DAMAGED COW CATCHER CORNER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING A SENSOR ERROR ALARM. THE BLOOD GLUCOSE READING WAS 146 MG/DL. THIS ALERT OCCURRED WHILE CUSTOMER WAS WAITING TO CALIBRATE AND AFTER THE INITIALIZATION PERIOD. CUSTOMER WAS ADVISED OF INSERTION TECHNIQUES AND STATED THAT THE SENSOR APPEARED TO BE FULLY INSERTED AND FLAT AGAINST THE SKIN. SHE STATED THAT THERE WAS NO DAMAGE ON THE CONNECTION BRIDGE OR CONTACT PINS. A TEST PLUG PROCEDURE WAS RUN AND SHOWED THAT THE TRANSMITTER MAY NOT BE WORKING. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430054 MINILINK TRANSMITTER CGM MDS MEDTRONIC MINIMED MMT-7703NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR