BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINILINK TRANSMITTER

    MDR report key: 4150345 · Received October 7, 2014

    Report

    Report Number
    2032227-2014-35028
    Event Type
    Injury
    Date Received
    October 7, 2014
    Date of Event
    September 1, 2014
    Report Date
    September 8, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    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 SHE FELL AND BROKE HER TIBIA. CUSTOMER WAS TAKEN TO THE HOSPITAL FOR HER BROKEN LEG AND HER BLOOD GLUCOSE READINGS INCREASED TO ABOUT 300 MG/DL TO 400 MG/DL AT THE HOSPITAL. CUSTOMER STATED THAT THE HOSPITAL HAD DIFFICULTY GETTING THE BLOOD GLUCOSE READINGS UNDER CONTROL AND THEREFORE WAS TAKEN OFF THE INSULIN PUMP. CUSTOMER'S BLOOD GLUCOSE READING AT THE TIME OF THE CALL WERE 201 MG/DL AND STATED THAT THEY ARE NOT WEARING THE INSULIN PUMP AS THEY WERE BEING TREATED AT THE HOSPITAL. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629815 MINILINK TRANSMITTER CGM MDS MEDTRONIC MINIMED MMT-7703NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization