BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 7775553 · Received August 11, 2018

    Report

    Report Number
    3004753838-2018-090802
    Event Type
    Malfunction
    Date Received
    August 11, 2018
    Date of Event
    July 12, 2018
    Report Date
    February 14, 2019
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    00386270000125
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). INITIALLY THIS EVENT WAS REPORTED AS A REPORTABLE MALFUNCTION. UPON FURTHER REVIEW IT WAS DETERMINED THAT THIS EVENT DOES NOT MEET THE CRITERIA OF A REPORTABLE COMPLAINT. 3004753838-2018-090802 WAS REPORTED IN ERROR. PLEASE DISREGARD INITIAL REPORTING OF THIS EVENT SINCE THIS HAS NOW BEEN DEEMED NON-REPORTABLE.

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON (B)(4) 2018 THAT ON (B)(6) 2018, A LOSS OF CONNECTION OCCURRED. NO PRODUCT WAS PROVIDED FOR EVALUATION HOWEVER DATA HAS BEEN RECEIVED FOR INVESTIGATION. A FOLLOW-UP WILL BE SUBMITTED UPON COMPLETION OF DATA INVESTIGATION. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MDR, IT WAS DETERMINED THAT THE REPORT WAS SUBMITTED IN ERROR. (B)(4) DID NOT OCCUR AND THEREFORE THE CRITERIA OF A REPORTABLE COMPLAINT IS NOT MET AS PER THE CODE OF FEDERAL REGULATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616238 DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR MDS DEXCOM, INC. 9438-05 5233450 00386270000125

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR