FDA Adverse Event
Malfunction
Summary report: N
DEXCOM FOLLOW APP
MDR report key: 22155585
·
Received June 5, 2025
Report
- Report Number
- 3004753838-2025-142572
- Event Type
- Malfunction
- Date Received
- June 5, 2025
- Date of Event
- June 2, 2025
- Report Date
- July 24, 2025
- Manufacturer
- DEXCOM, INC.
- Product Code
- QBJ
- PMA / PMN Number
- DEN140038
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
(B)(4).
Additional Manufacturer Narrative · 0
(B)(4). MFR 3004753838-2025-142572 WAS REPORTED IN ERROR. PLEASE DISREGARD INITIAL REPORTING OF THIS EVENT AS THIS EVENT HAS NOW BEEN DEEMED NON-REPORTABLE.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE READINGS FROZE. DATA WAS PROVIDED FOR INVESTIGATION. CONFIRMATION OF THE COMPLAINT WAS UNDETERMINED VIA DATA. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. 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 |
|---|---|---|---|---|---|---|---|
| 1493311 | DEXCOM FOLLOW APP | CONTINUOUS GLUCOSE MONITOR | QBJ | DEXCOM, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Male |