BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR BSA

    MDR report key: 3171136 · Received June 14, 2013

    Report

    Report Number
    2032227-2013-02460
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 22, 2013
    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. PLEASE SEE ALSO MFR REPORT NUMBER 3004209178-2013-94524.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED TO REPORT DISCREPANCIES BETWEEN THE SENSOR GLUCOSE AND BLOOD GLUCOSE READINGS. THE CUSTOMER REPORTED A BLOOD GLUCOSE OF 24 MG/DL, BUT A SENSOR GLUCOSE OF 89 MG/DL. THE CUSTOMER THEN STATED THAT THERE WERE THREE HOSPITALIZATIONS DUE TO LOW BLOOD GLUCOSE LEVELS. THE FIRST EVENT WAS TEN YEARS AGO. THE CUSTOMER WAS DRIVING, AND WAS IN AN ACCIDENT BECAUSE HIS GLUCOSE MONITOR DIDN'T ALERT HIM OF HIS LOW BLOOD GLUCOSE LEVELS. THE SECOND EVENT WAS FIVE YEARS AGO. THE CUSTOMER WAS IN THE HOSPITAL WITH LOW BLOOD GLUCOSE LEVELS, AND AGAIN, THE GLUCOSE MONITOR DIDN'T ALERT HIM OF HIS LOW BLOOD GLUCOSE. THE THIRD EVENT WAS ALSO FIVE YEARS AGO. THE CUSTOMER WAS HOSPITALIZED AFTER EXPERIENCING LOW BLOOD GLUCOSE LEVELS AND A SEIZURE. THE CUSTOMER HAD NO FURTHER INFORMATION AS THESE EVENTS WERE SO LONG AGO. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271769 SENSOR BSA CGM MDS MEDTRONIC MINIMED MMT-7002C

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization