BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINILINK TRANSMITTER

    MDR report key: 4132378 · Received October 1, 2014

    Report

    Report Number
    2032227-2014-31244
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    September 1, 2014
    Report Date
    September 1, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    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

    CUSTOMER REPORTED SHE IS RECEIVING LOST SENSOR ALARMS. THIS HAPPENS FREQUENTLY. CUSTOMER'S BLOOD GLUCOSE IS 495 MG/DL. SHE TREATED WITH HER INSULIN PUMP AND MANUAL INJECTIONS. CUSTOMER THINKS THE CHARGER IS NOT HOLD A CHARGE ANYMORE. CUSTOMER CONNECTED THE TRANSMITTER TO THE TEST PLUG, BUT THE GREEN LED DID NOT BLINK ON AND OFF FOR TEN SECONDS. A NEW CHARGER WAS SENT TO MAKE ELIMINATE THE POSSIBILITY OF THE CHARGER BEING FAULTY. CUSTOMER WILL CALL BACK TO COMPLETE TROUBLESHOOTING. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612992 MINILINK TRANSMITTER CGM MDS MEDTRONIC MINIMED MMT-7703NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention