BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINILINK TRANSMITTER

    MDR report key: 3930844 · Received July 12, 2014

    Report

    Report Number
    2032227-2014-03578
    Event Type
    Malfunction
    Date Received
    July 12, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 12, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    PATIENT

    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

    IT WAS REPORTED THAT THE SENSOR DISPLAYED LOST SENSOR AFTER THREE DAYS ON THREE DIFFERENT SENSORS. CUSTOMER CHECKED THE SITE AND EVERYTHING WAS INTACT. CUSTOMER TRIED TO RECONNECT THE SENSOR, BUT SHE RECEIVED LOST SENSOR ALERT. THE BLOOD GLUCOSE READING IS 75 MG/DL. CUSTOMER STATES SHE ALWAYS CHARGES THE TRANSMITTER. AFTER TROUBLESHOOTING, THE TRANSMITTER MAY NOT HOLD A CHARGE. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408587 MINILINK TRANSMITTER CGM MDS MEDTRONIC MINIMED MMT-7703NA A000306169

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR