BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 19377583 · Received May 22, 2024

    Report

    Report Number
    3004753838-2024-123087
    Event Type
    Malfunction
    Date Received
    May 22, 2024
    Date of Event
    March 7, 2024
    Report Date
    June 13, 2024
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270003584
    PMA / PMN Number
    K213919
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 3004753838-2024-123087 WAS REPORTED IN ERROR. PLEASE DISREGARD INITIAL REPORTING OF THIS EVENT AS THIS EVENT HAS NOW BEEN DEEMED NOT REPORTABLE.

    Additional Manufacturer Narrative · 0

    CMPL-(B)(4).

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A WEARABLE FAILURE OCCURRED. THE SENSOR WAS INSERTED INTO THE ABDOMEN ON (B)(6) 2024. OFF-LABEL : ALTERNATE SITE INSERTION. PERFORMANCE DATA WAS REVIEWED. THE ALLEGATION WAS NOT CONFIRMED. HOWEVER, AN EARLY SENSOR EXPIRATION WAS FOUND IN CONNECTION TO THE REPORTED ALLEGATION. THE PROBABLE CAUSE OF THE EARLY SENSOR EXPIRATION COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1789145 DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9500-160 1823237001 00386270003584

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Female