BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINILINK TRANSMITTER

    MDR report key: 4150356 · Received October 7, 2014

    Report

    Report Number
    2032227-2014-35025
    Event Type
    Malfunction
    Date Received
    October 7, 2014
    Date of Event
    July 30, 2014
    Report Date
    September 8, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    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 THEIR BLOOD GLUCOSE READINGS WENT SEVERELY LOW DUE TO A POSSIBLE TRANSMITTER ISSUE. IT WAS NOTED THAT THE LOW BLOOD GLUCOSE READINGS MADE THE CUSTOMER HAVE SEIZURES AND HIS WIFE TREATED HIM WITH GLUCAGON. THROUGH TROUBLESHOOTING IT WAS NOTED THAT THE MINILINK MAY NOT BE WORKING. CUSTOMER'S BLOOD GLUCOSE READING AT THE TIME OF THE CALL WAS170 MG/DL. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628710 MINILINK TRANSMITTER CGM MDS MEDTRONIC MINIMED MMT-7703NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR