BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR

    MDR report key: 3800815 · Received May 8, 2014

    Report

    Report Number
    2032227-2014-02131
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    April 15, 2014
    Report Date
    April 18, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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. PLEASE SEE ALSO MFR. REPORT NUMBER 3004209178-2014-84310.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WEARS THE SENSORS, AND HAS HAD THREE REACTIONS IN THE PAST THREE WEEKS, AND WAS RECENTLY TREATED BY THE PARAMEDICS DUE TO A LOW BLOOD GLUCOSE OF 35 MG/DL. IT WAS ALSO STATED THAT THE PATIENT'S BLOOD GLUCOSE WAS 7 MG/DL LAST NIGHT, BUT THE SENSOR GLUCOSE READING WAS 98 MG/DL. TROUBLESHOOTING REVEALED THAT THE PATIENT ONLY CALIBRATES TWICE A DAY. ALSO, FOUND THAT THE PATIENT HAS BEEN ENTERING "FAKE" BLOOD GLUCOSE READINGS IN ORDER TO GET THE BLOOD GLUCOSE AND SENSOR READINGS CLOSER TOGETHER. ADVISED THE CALLER ON PROPER PROTOCOL FOR USING THE SENSOR. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278562 SENSOR OZO OZO MEDTRONIC MINIMED MMT-7008

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention