BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 4130257 · Received September 30, 2014

    Report

    Report Number
    3004753838-2014-29342
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Date of Event
    January 31, 2014
    Report Date
    February 3, 2014
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING COMPLAINT CLOSURE REVIEW, IT WAS DETERMINED THAT THIS COMPLAINT IS A REPORTABLE EVENT. CUSTOMER COMPLAINT COULD NOT BE CONFIRMED, AS NO DATA OR PRODUCT WAS PROVIDED FOR INVESTIGATION. THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    PATIENT'S HUSBAND CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 TO REPORT ON (B)(6) 2014, UPON SENSOR POD REMOVAL, THE SENSOR WIRE REMAINED ATTACHED TO THE APPLICATOR. PATIENT'S HUSBAND DID NOT REPORT ANY INJURY OR MEDICAL INTERVENTION AT THE TIME OF CONTACT WITH DEXCOM TECHNICAL SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608038 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-25 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR