FDA Adverse Event
Malfunction
Summary report: N
DEXCOM CLARITY SOFTWARE
MDR report key: 15987464
·
Received December 15, 2022
Report
- Report Number
- 3004753838-2022-234082
- Event Type
- Malfunction
- Date Received
- December 15, 2022
- Date of Event
- November 17, 2022
- Report Date
- February 27, 2023
- Manufacturer
- DEXCOM, INC.
- Product Code
- QBJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
(B)(4). MFR 3004753838-2022-234082 WAS REPORTED IN ERROR. PLEASE DISREGARD INITIAL REPORTING OF THIS EVENT AS THIS EVENT HAS NOW BEEN DEEMED NOT REPORTABLE.
Additional Manufacturer Narrative · 0
(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 MOBILE APP INTERRUPTION DUE TO OS UPGRADE ON SMART DEVICE OCCURRED. NO DATA OR PRODUCT WAS PROVIDED FOR INVESTIGATION. THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1484936 | DEXCOM CLARITY SOFTWARE | CONTINUOUS GLUCOSE MONITOR | QBJ | DEXCOM, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male |