BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORS

    MDR report key: 3715374 · Received March 31, 2014

    Report

    Report Number
    3004753838-2014-11520
    Event Type
    Malfunction
    Date Received
    March 31, 2014
    Date of Event
    August 27, 2013
    Report Date
    September 18, 2013
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS TO FOLLOW UP WITH HIS DOCTOR (MD) TWO WEEKS AFTER HIS (B)(6) 2013 REGULAR DOCTOR'S VISIT. HE WAS SCHEDULED TO SEE CHIEF OF STAFF ON (B)(6) 2013 AT (B)(6) CLINIC. CURRENT CONDITION OF PATIENT AT THE TIME OF REPORT: FINE. THE PATIENT HAS NOT PROVIDED ANY ADDITIONAL INFORMATION AFTER (B)(6) 2013. BROKEN SENSOR WIRE AND BURNING WAS ALREADY REPORTED TO FDA (U.S. FOOD AND DRUG ADMINISTRATION) BY DEXCOM, INC. ON (B)(6) 2013 UNDER MANUFACTURER REPORT NUMBER 3004753838-2013-00303.

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM TO REPORT A BROKEN SENSOR WIRE, BLEEDING, AND BURNING. THE SENSOR WIRE BROKE DURING SENSOR INSERTION. THE PATIENT SAYS HE PLUNGED, RETRACED, PATIENT WAS ABLE TO SNAP THE TRANSMITTER INTO THE SENSOR POD, SAW BLEEDING ON THE ADHESIVE PATCH, THEN PEELED THE ADHESIVE BACK AND SAW THE SENSOR WIRE WAS BROKEN AND PROTRUDING FROM THE SKIN ABOUT 1/16 OF AN INCH. HE USED TWEEZERS AND REMOVED THE SENSOR WIRE REMAINING IN THE SKIN, STOPPED BLEEDING WITH AN ALCOHOL SWAB, NO PERMANENT MARK, BUT HAD A BURNING FEELING AT THE INSERTION SITE WHEN PATIENT LAID ON HIS SIDE. THE PATIENT SAW HIS REGULAR DOCTOR OF MEDICINE (MD) ON (B)(6) 2013. THE MD THOUGHT THE PATIENT COULD HAVE AN INFECTION SINCE HE WAS HAVING ELEVATED BLOOD PRESSURE BUT THE MD DID NOT SEE ANY VISIBLE SIGN OF INFECTION. MD DID NOT PRESCRIBE ANY MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189150 G4 PLATINUM CONTINUOUS GLUCOSE MONITORS MDS, PRODUCT CODE, MDS MDS DEXCOM, INC. 9500-27 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other DILTIAZEM (180MG)| RANEXA (RANOLAZINE)| CAPOTEN (CAPTOPRIL)| CLOPIDOGREL (75MG)| BELVIQ (LORCASERIN)