DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
Report
- Report Number
- 3004753838-2021-140117
- Event Type
- Malfunction
- Date Received
- August 11, 2021
- Date of Event
- July 20, 2021
- Report Date
- October 29, 2021
- Manufacturer
- DEXCOM, INC.
- Product Code
- QBJ
- PMA / PMN Number
- DEN170088
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
(B)(4). G6 ¿FOLLOW-UP NUMBER¿ FIELD UPDATED FROM [¿N¿] TO [¿N+1¿] AS THE SUPPLEMENTAL REPORT SUBMITTED UNDER FOLLOW-UP NUMBER [¿N¿] FAILED DUE TO AN ERROR WITH THE AS2 CERTIFICATE, WHICH HAS SINCE BEEN CORRECTED.¿
(B)(4).
IT WAS REPORTED THAT SIGNAL LOSS OVER ONE HOUR OCCURRED. THE PRODUCT WAS EVALUATED. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. VOLTAGE TESTING WAS PERFORMED AND FAILED. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
IT WAS REPORTED THAT SIGNAL LOSS OVER ONE HOUR OCCURRED. THE PRODUCT WAS EVALUATED. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. VOLTAGE TESTING WAS PERFORMED AND FAILED. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
(B)(4).
IT WAS REPORTED THAT SIGNAL LOSS OVER ONE HOUR OCCURRED. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. CONFIRMATION OF THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1207839 | DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | QBJ | DEXCOM, INC. | MT25042-4 | 7284961 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR |