BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINILINK TRANSMITTER

    MDR report key: 3972176 · Received July 31, 2014

    Report

    Report Number
    2032227-2014-05127
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 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

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FAILED TRANSMITTING DUE TO DAMAGED COW CATCHER CORNERS AND DAMAGED CONTACT PIN.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING A SENSOR ERROR. CUSTOMER STATED THAT HE WAS ON HIS THIRD SENSOR AND FELT THAT THE ISSUE WAS RELATED TO THE TRANSMITTER. CUSTOMER STATED THAT HE TOOK TOO MUCH INSULIN, RESULTING IN A BLOOD GLUCOSE READING OF 50 MG/DL. HE TREATED WITH GLUCOSE TABLETS. CUSTOMER FOUND NO DAMAGE ON THE CONNECTION BRIDGE OF THE TRANSMITTER. A TEST PLUG PROCEDURE WAS RUN AND SHOWED THAT THE TRANSMITTER WAS NOT FUNCTIONING PROPERLY. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447879 MINILINK TRANSMITTER CGM MDS MEDTRONIC MINIMED MMT-7703NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR