BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINILINK TRANSMITTER

    MDR report key: 3864621 · Received June 10, 2014

    Report

    Report Number
    2032227-2014-03032
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    May 20, 2013
    Report Date
    May 23, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    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 CALLED TO REPORT THAT HE WAS HOSPITALIZED IN (B)(6) 2013 DUE TO LOW BLOOD GLUCOSE. THE BLOOD GLUCOSE READING WAS 40 MG/DL AT THE TIME OF ADMISSION. CUSTOMER STATED THAT HE WAS IN VACATIONS AND THE PARAMEDICS WERE CALLED TWICE IN (B)(6) 2014 DUE TO LOW BLOOD GLUCOSE. CUSTOMER STATED THAT HE REFUSED TO GO TO THE HOSPITAL AND HE WAS TREATED AT SCENE. CUSTOMER STATED THAT HE DID NOT EAT AND IT MAY BE THE CAUSED OF THE LOW BLOOD GLUCOSE. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341239 MINILINK TRANSMITTER CGM MDS MEDTRONIC MINIMED MMT-7703NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization