BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 1812155 · Received August 16, 2010

    Report

    Report Number
    3004753838-2010-00161
    Event Type
    Injury
    Date Received
    August 16, 2010
    Date of Event
    July 25, 2010
    Report Date
    July 27, 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

    PT'S SISTER REPORTED THAT PT WAS PROVIDED GLUCOSE BY PARAMEDICS AFTER BECOMING HYPOGLYCEMIC. PT'S SISTER STATED THAT PT'S FINGER STICK MEASUREMENT WAS 21 MG/DL. PT'S SISTER WAS UNSURE WHAT THE CGM READING WAS AT THE TIME OF THE EVENT, BUT REPORTED THAT PT HAD NOT RECEIVED AN ALERT. PT'S SISTER STATED THAT PT HAD TAKEN ACETAMINOPHEN EARLIER IN THE DAY DESPITE THE CONTRAINDICATION PROVIDED IN DEXCOM'S PRODUCT LABELING. PT WAS DOING FINE AT THE TIME OF HER SISTER'S CALL TO DEXCOM TECHNICAL SUPPORT.

    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 53 YR Other