BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 2062750 · Received April 14, 2011

    Report

    Report Number
    3004753838-2011-00109
    Event Type
    Injury
    Date Received
    April 14, 2011
    Date of Event
    February 14, 2011
    Report Date
    March 3, 2011
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P050012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PER MDR REPORTING REQUIREMENTS, THIS EVENT IS NOT REPORTABLE. DUE TO THE SERIOUSNESS OF THE INJURY AND THE NECESSITY FOR MEDICAL INTERVENTION, HOWEVER, DEXCOM IS REPORTING THIS EVENT.

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2011 TO REPORT THAT SHE EXPERIENCED TWO INCIDENTS OF EXTREME LOWS REQUIRING MEDICAL INTERVENTION. SHE REPORTED THAT THE INCIDENTS OCCURRED WHILE SHE WAS ASLEEP. SHE REPORTED THAT SHE DID NOT HEAR HER LOW ALARMS/ALERTS AND PASSED OUT. PARAMEDICS WERE CALLED ON BOTH OCCASIONS AND ADMINISTERED GLUCAGON ON ONE OF THESE OCCASIONS. PATIENT REPORTED THAT HER DEVICE WORKS WELL AND CGM VALUES ARE ACCURATE; SHE JUST FEELS THAT THE VOLUME NEEDS TO BE LOUDER. PATIENT WAS FINE AT THE TIME OF HER CALL TO DEXCOM TECHNICAL SUPPORT. THIS IS MDR 2 OR 2 FOR THE COMPLAINT. SEE MDR #3004753838-2011-00108 FOR REPORT 1 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR MDS DEXCOM, INC. 8219-15

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other