BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 19075686 · Received April 9, 2024

    Report

    Report Number
    3004753838-2024-083556
    Event Type
    Malfunction
    Date Received
    April 9, 2024
    Date of Event
    March 17, 2024
    Report Date
    April 24, 2024
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270001047
    PMA / PMN Number
    DEN170088
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). 3004753838-2024-083556 WAS REPORTED IN ERROR. PLEASE DISREGARD INITIAL REPORTING OF THIS EVENT AS THIS EVENT HAS NOW BEEN DEEMED NOT REPORTABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT EARLY SENSOR EXPIRATION OCCURRED. THE SENSOR WAS INSERTED INTO THE ABDOMEN ON (B)(6) 2024. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE INITIAL MDR, IT WAS DETERMINED THAT A REPORT WAS SUBMITTED IN ERROR. UPON FURTHER REVIEW, IT WAS DETERMINED THAT THE PATIENT ALLEGATION DOES NOT MEET THE CRITERIA OF A REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512957 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9535-45 7336198 00386270001047

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female