BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 2543052 · Received April 11, 2012

    Report

    Report Number
    3004753838-2012-00095
    Event Type
    Other
    Date Received
    April 11, 2012
    Date of Event
    March 15, 2012
    Report Date
    March 16, 2012
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P050012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEXCOM, INC. AND FDA AGREED DURING A FACILITY INSPECTION THAT ANY POSSIBLE BROKEN SENSOR WIRE WAS A REPORTABLE EVENT, EVEN IN THE ABSENCE OF ANY EVIDENCE OF PHYSICAL HARM OR NECESSITY FOR INTERVENTION.

    Description of Event or Problem · 1

    NURSE CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2012, ON BEHALF OF ONE OF THEIR PEDIATRIC PATIENTS, TO REPORT THAT SENSOR WIRE HAD BECOME DETACHED FROM THE ABDOMEN WHILE PATIENT WAS SLEEPING. PATIENT'S PARENTS COULD NOT FIND SENSOR IN BED NOR ON PATIENT'S SKIN. AT THE TIME OF HER CALL TO DEXCOM TECHNICAL SUPPORT ON (B)(6) 2012, NURSE REPORTED THAT PATIENT WAS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR MDS DEXCOM, INC. 9500-03 5037902

    Patients

    Seq Age Sex Outcome Treatment
    1 Other