Dexcom G7 Continuous Glucose Monitoring System · Continuous Glucose Monitor
Dexcom, Inc. · Wireless Communication Problem
- Manufacturer contact state
- CA
- Manufacturer link flag
- Y
- Manufacturer contact address 1
- 6340 Sequence Dr.
- Manufacturer contact pcity
- +1(858)2
- Event type
- Malfunction
- Report number
- 3004753838-2026-222780
- Product problem flag
- Y
- Date received
- 20260831
- PMA pmn number
- K213919
- Date of event
- 20260714
- Reprocessed and reused flag
- N
- Manufacturer contact zip code
- 92121
- Manufacturer contact plocal
- +1(858)200-0200
- Noe summarized
- 1
- Manufacturer contact l name
- Chavez
- Reporter country code
- US
- Date added
- 20260831
- Manufacturer contact f name
- Jaime
- Previous use code
- I
- Suppl dates mfr received
- 08/12/2026
- Manufacturer contact country
- US
- Date changed
- 20260901
- Health professional
- N
- Summary report flag
- N
- Date report
- 20260831
- Manufacturer contact city
- San Diego
- MDR report key
- 50224235
- Date manufacturer received
- 20260714
- Report source code
- Manufacturer report
- Adverse event flag
- N
- Single use flag
- Y
- Manufacturer contact postal code
- 92121
- Suppl dates FDA received
- 08/31/2026
- Type of report
- Initial submission, Followup
- Source type
- Foreign, Consumer
- Device
- Device sequence number
- 411787
- Serviced by 3rd party flag
- N
- Date received
- 20260831
- Brand name
- Dexcom G7 Continuous Glucose Monitoring System
- Generic name
- Continuous Glucose Monitor
- Manufacturer d name
- Dexcom, Inc.
- Manufacturer d address 1
- 6340 Sequence Dr.
- Manufacturer d city
- San Diego
- Manufacturer d state
- CA
- Manufacturer d zip code
- 92121
- Manufacturer d country
- US
- Manufacturer d postal code
- 92121
- Device operator
- LAY USER/PATIENT
- Catalog number
- STE-GT-002
- Device availability
- No
- Device report product code
- QBJ
- Device evaluated by manufacturer
- N
- Combination product flag
- N
- UDI di
- 00386270004079
- UDI public
- (01)00386270004079
- Harmonized identifiers (openFDA)
- Device name
- Integrated Continuous Glucose Monitoring System, Factory Calibrated
- Medical specialty description
- Clinical Chemistry
- Regulation number
- 862.1355
- Device class
- 2
- Product problems
- Wireless Communication Problem
- Patient
- Patient sequence number
- 1
- Date received
- 20260831
- Patient age
- 53 YR
- Patient sex
- Female
- Patient problems
- No Clinical Signs, Symptoms or Conditions
- MDR text
- MDR text key
- 16128370742
- Text type code
- Additional Manufacturer Narrative
- Patient sequence number
- 0
- Text
- (B)(4). Please disregard initial reporting of this event as this event has now been deemed Not Reportable.
- MDR text key
- 15628370736
- Text type code
- Description of Event or Problem
- Patient sequence number
- 0
- Text
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.