BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3433646 · Received October 28, 2013

    Report

    Report Number
    3004753838-2013-00323
    Event Type
    Injury
    Date Received
    October 28, 2013
    Date of Event
    September 29, 2013
    Report Date
    September 29, 2013
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED AND THE SENSOR WIRE WAS FOUND TO BE MISSING FROM THE HOUSING PUCK. DUE TO THE SEPARATION OF SENSOR WIRE, THE SENSOR WIRE IS CONSIDERED TO BE DETACHED. WITHOUT A SENSOR WIRE, MEASUREMENTS COULD NOT BE TAKEN. THEREFORE THE COMPLAINT OF FRACTURE WIRE COULD NOT BE CONFIRMED BECAUSE THE SENSOR WIRE WAS NOT RETURNED.

    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

    PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2013 TO REPORT THAT ON (B)(6) 2013, UPON WIRE REMOVAL, PATIENT WAS UNABLE TO LOCATE SENSOR. PATIENT WAS CONCERNED THAT WHOLE OR A FRAGMENT OF THE WIRE MAY HAVE REMAINED UNDER HIS SKIN. PATIENT REPORTS THAT HE DOESN¿T EXPERIENCE ANY PAIN NOR REDNESS OR IRRITATION AT THE INSERTION SITE. PATIENT CONSULTED WITH HIS PHYSICIAN AND REPORTED THAT AN X-RAY SHOWED A WIRE OF 5-10 MM UNDER HIS SKIN AND WAS ORIGINALLY SCHEDULED FOR SURGICALLY REMOVING THE WIRE FROM HIS BODY. IN A SUBSEQUENT EMAIL, PATIENT REPORTED TO DEXCOM THAT HIS PHYSICIAN HAD ADVISED AGAINST THE SURGICAL REMOVAL OF THE SENSOR FROM HIS SKIN SINCE SENSOR WIRE WAS NOT BOTHERING PATIENT. PATIENT HAS AGREED TO SEND CGM DATA FOR DEXCOM TO INVESTIGATE CGM VALUES AROUND THE TIME OF THE HYPOGLYCEMIC EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    550862 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-27 5081045

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other