BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 1923554 · Received December 6, 2010

    Report

    Report Number
    3004753838-2010-00209
    Event Type
    Injury
    Date Received
    December 6, 2010
    Date of Event
    October 30, 2010
    Report Date
    November 17, 2010
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P050012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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

    PATIENT'S FATHER CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2010, TO REPORT THAT HIS SON EXPERIENCED CGM INACCURACIES. PATIENT'S FATHER REPORTED THAT PATIENT'S CGM WAS READING HIGH AND PT DID NOT HAVE HIS BLOOD GLUCOSE MONITOR WITH HIM TO CONFIRM WITH A FINGERSTICK, SO HE GAVE HIMSELF INSULIN BASED ON THE HIGH CGM READING. AFTER DOSING WITH INSULIN, PT DID NOT FEEL WELL AND PASSED OUT. PT WAS TAKEN TO A "CENTER," WHERE THEY DISCOVERED HIS BLOOD GLUCOSE WAS 18 MG/DL. PT WAS GIVEN TWO GLUCAGON SHOTS AND WAS REVIVED. PT WAS SENT HOME AND WAS DOING FINE AT THE TIME OF HIS FATHER'S CALL TO DEXCOM TECHNICAL SUPPORT. PATIENT'S FATHER INDICATED THAT HE DID NOT KNOW IF PT WAS TAKING ANYTHING CONTAINING ACETAMINOPHEN OR WHETHER HE WAS CALIBRATING EVERY 12 HOURS. HE STATED THAT PT HAS SEVERAL OTHER HEALTH ISSUES AND THAT, DUE TO OTHER HEALTH CIRCUMSTANCES, IT IS NOT UNORDINARY FOR PATIENT'S BLOOD SUGAR TO SEVERELY FLUCTUATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR MDS DEXCOM, INC. 9500-03

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Other