BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINILINK TRANSMITTER

    MDR report key: 3945778 · Received July 21, 2014

    Report

    Report Number
    2032227-2014-04703
    Event Type
    Malfunction
    Date Received
    July 21, 2014
    Date of Event
    June 19, 2014
    Report Date
    June 19, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    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 THE INSULIN PUMP ALARMED LOST SENSOR, SENSOR AND INSULIN PUMP WERE NOT COMMUNICATING. TROUBLESHOOTING WAS PERFORMED. CUSTOMER'S BLOOD GLUCOSE WAS 106 MG/DL. CUSTOMER STATED THE CORRECT TRANSMITTER ID IS INPUTTED IN THE INSULIN PUMP. ALARM WAS EXPLAINED TO THE CUSTOMER. ALERT WAS VERIFIED. THE SENSOR WAS INSERTED ON (B)(6) 2014. SENSOR APPEARS TO BE FULLY INSERTED AND FLUSHED TO THE SKIN. ALERT OCCURRED WHILE CUSTOMER WAS GOING TO THE DOCTOR'S OFFICE AND AFTER INITIALIZATION. CUSTOMER STATE THE INSULIN PUMP DID NOT HAVE OTHER ALARMS PRIOR TO LOST SENSOR. RADIO FREQUENCY COMMUNICATION WAS NOT ESTABLISHED. CUSTOMER WAS ADVISED TO DISCONNECT SENSOR AND TRANSMITTER. TEST PLUG WAS PERFORMED ON THE TRANSMITTER. NO DAMAGE NOTED ON THE DEVICE. THE DEVICE'S LED BLINK INDICATING IT IS PERFORMING CORRECTLY. TRIED TO CONNECT RADIO FREQUENCY AND IT DID NOT TURN SOLID. TEST PERFORMED TWICE AND DID NOT CONNECT. CUSTOMER ADVISED TRANSMITTER MIGHT NOT BE WORKING. NO FURTHER INFORMAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425670 MINILINK TRANSMITTER CGM MDS MEDTRONIC MINIMED MMT-7703NA A000294088

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR