BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINILINK TRANSMITTER

    MDR report key: 4123153 · Received September 26, 2014

    Report

    Report Number
    2032227-2014-29484
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    June 30, 2014
    Report Date
    June 30, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE TRANSMITTER WAS RECEIVED WITH ISIG VALUE OUT OF RANGE (0.00NA) DUE TO DAMAGED CONTACT PIN #1.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THEIR TRANSMITTER WAS NOT COMMUNICATING CALIBRATION INFORMATION AND THE DEVICE ALARMED. CUSTOMER STATES THAT THEY CHARGED THE SENSOR FULLY AND CONTINUE TO RECEIVE THE ERROR ALARM. DURING TROUBLESHOOTING, CUSTOMER WAS ASKED IF THE DEVICE SENSOR WAS FLAT AGAINST THEIR SKIN. CUSTOMER STATED IT WAS. NEXT, CUSTOMER WAS ASKED TO ATTACH THE SENSOR TO THE CHARGER. CUSTOMER STATED THE DEVICE FLASHED RED AND THAT THEY HAVE NEVER CHANGED THE BATTERY BEFORE. AFTERWARDS, CUSTOMER WAS ADVISED TO REINSERT DEVICE. CUSTOMER STATES DEVICE IS NOT FUNCTIONING. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 77 MG/DL AT TIME OF REPORTING. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602636 MINILINK TRANSMITTER CGM MDS MEDTRONIC MINIMED MMT-7703NA

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR