BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINILINK TRANSMITTER

    MDR report key: 4103476 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-26378
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 21, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK
    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 THAT HER BLOOD GLUCOSE VALUE WAS 408 MG/DL; TREATING WITH INSULIN BOLUS DOSE. CUSTOMER STATED THAT HER BLOOD GLUCOSE VALUE WAS HIGH DUE TO NOT GIVING HERSELF ENOUGH INSULIN BOLUS. CUSTOMER STATED THAT THE INSULIN PUMP IS WORKING AND DECLINED TO TROUBLESHOOT FOR HIGH BLOOD GLUCOSE. CUSTOMER ALSO REPORTED THAT THE LED LIGHT ON THE TRANSMITTER IS NOT BLINKING WHEN CONNECTED TO THE SENSOR. CUSTOMER WAS ADVISED TO CHARGE THE TRANSMITTER AND RECONNECTED IT TO THE SENSOR; CUSTOMER STATED IT IS STILL NOT COMMUNICATING. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584492 MINILINK TRANSMITTER CGM MDS MEDTRONIC MINIMED MMT-7703NA A000323549

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR