DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
Report
- Report Number
- 3004753838-2025-173642
- Event Type
- Malfunction
- Date Received
- July 7, 2025
- Date of Event
- June 13, 2025
- Report Date
- October 20, 2025
- Manufacturer
- DEXCOM, INC.
- Product Code
- QBJ
- UDI-DI
- 00386270003935
- PMA / PMN Number
- K213919
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(B)(4).
(B)(4). MFR NO 3004753838-2025-173642 WAS REPORTED IN ERROR. PLEASE DISREGARD INITIAL REPORTING OF THIS EVENT AS THIS EVENT HAS NOW BEEN DEEMED NOT REPORTABLE.
(B)(4). VOLUNTARY MEDWATCH REPORT NUMBER MW5171687 B5 DESCRIBE EVENT OR PROBLEM - ADDITIONAL INFORMATION D9 DEVICE RETURNED TO MFR - ADDITIONAL INFORMATION D9 DATE DEVICE RETURNED - ADDITIONAL INFORMATION E4 INITIAL REPORT ALSO SEND TO FDA - ADDITIONAL INFORMATION G2 REPORT SOURCE - ADDITIONAL INFORMATION G2 REPORT SOURCE OTHER - ADDITIONAL INFORMATION G3 DATE RECEIVED BY MFG - ADDITIONAL INFORMATION G6 TYPE OF REPORT - UPDATED/FOLLOW-UP H2 TYPE OF FOLLOW UP - ADDITIONAL INFORMATION H6 CODES: TYPE OF INVESTIGATION - ADDITIONAL INFORMATION H6 CODES: INVESTIGATION FINDINGS - ADDITIONAL INFORMATION H6 CODES: INVESTIGATION CONCLUSION - ADDITIONAL INFORMATION. H11 ADDITIONAL NARRATIVE - ADDITIONAL INFORMATION.
(B)(4).
IT WAS REPORTED THAT A DETACHED OR MISSING SENSOR WIRE OCCURRED. THE SENSOR WAS INSERTED INTO THE ARM ON (B)(6) 2025. 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.
AFTER SUBMISSION OF THE INITIAL MDR, PRODUCT WAS RECEIVED ON 7/9/2025 AND IT WAS DETERMINED THIS COMPLAINT IS NOT REPORTABLE PER (B)(4).
A VOLUNTARY MEDWATCH REPORT WAS RECEIVED ON 7/2/2025. PRODUCT HAS BEEN RECEIVED BUT IS PENDING EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
SUBSEQUENT TO THE INITIAL SUPPLEMENTAL, A CORRECTION IS REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 141651 | DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | QBJ | DEXCOM, INC. | 9500-161 | 1824318001 | 00386270003935 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Male | TANDEM TSLIM. |