BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 10425326 · Received August 19, 2020

    Report

    Report Number
    3004753838-2020-082826
    Event Type
    Malfunction
    Date Received
    August 19, 2020
    Date of Event
    July 20, 2020
    Report Date
    September 18, 2020
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270000385
    PMA / PMN Number
    DEN170088
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). G4: DATE RECEIVED BY MANUFACTURER ¿ CORRECTION (PLEASE SEE BELOW) H2: IF FOLLOW-UP, WHAT TYPE ¿ CORRECTION THE PREVIOUS SUPPLEMENTAL REPORT (FOLLOW-UP REPORT # 1) FOR THIS MFR NUMBER 3004753838-2020-082826 STATED A DATE OF AWARENESS OF (B)(6) 2020 IN THE G4 DATE RECEIVED BY MANUFACTURER FIELD. THIS SHOULD HAVE BEEN (B)(6) 2020 WHICH IS WHY THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE INITIAL MDR, A CORRECTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TRANSMITTER FAILED ERROR OCCURRED. DATA WAS EVALUATED AND THE ALLEGATION WAS CONFIRMED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TRANSMITTER FAILED ERROR OCCURRED. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. CONFIRMATION OF THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    890543 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9445-02 7271529 00386270000385

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR