DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
Report
- Report Number
- 3004753838-2022-153456
- Event Type
- Malfunction
- Date Received
- August 22, 2022
- Date of Event
- July 28, 2022
- Report Date
- November 7, 2022
- Manufacturer
- DEXCOM, INC.
- Product Code
- QBJ
- UDI-DI
- 00386270001788
- PMA / PMN Number
- DEN170088
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(B)(4).
(B)(4).
(B)(4). THIS MDR WAS PREVIOUSLY SUBMITTED ON 9/28/2022 WITH MFR# 3004753838-2022-153456-01. THE ACK2 WAS RECEIVED ON 9/28/2022 BY CDRH WITH COREID: CI1664401219133.12942087@FDSLV86002_TE2. PER ESG/CDRH EMAIL ON 9/30/2022, ¿ THE CESUB HELPDESK HAS COMMUNICATED THEY ARE AWARE OF MULTIPLE MDRS THAT FAILED TO PROCESS AND MULTIPLE ACK3S THAT FAILED TO SEND BETWEEN SEPTEMBER 7 AND SEPTEMBER 26 DUE TO AN INFRASTRUCTURE ISSUE, AND THEY ARE WORKING AS FAST AS THEY CAN TO REPROCESS THE MDRS THAT NEED TO BE REPROCESSED AND RESEND ACK3S THAT FAILED TO SEND. THEIR GOAL IS TO COMPLETE THIS TASK AND RESPOND TO ALL OPEN ACK3 TICKETS BY OCTOBER 7.¿ AS OF OCTOBER 28, 2022, THE ISSUE HAS NOT BEEN RESOLVED. AS PER ESG/CDRH EMAIL ON 10/28/2022, WE SHOULD NOW RESUBMIT THIS MDR.
IT WAS REPORTED THAT SIGNAL LOSS OVER ONE HOUR OCCURRED. A REVIEW OF THE SHARE LOGS WAS PERFORMED AND A LOSS OF CONNECTION WAS FOUND WITHIN THE INVESTIGATION WINDOW. HOWEVER, THE DEVICE OPERATED WITHIN SPECIFICATION. THE ALLEGATION WAS NOT CONFIRMED. 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 TEST WAS PERFORMED AND PASSED. PAIRING TEST WAS PERFORMED AND PASSED. A REVIEW OF THE SHARE LOGS WAS PERFORMED AND SIGNAL LOSS WAS FOUND WITHIN THE INVESTIGATION WINDOW. HOWEVER, THE DEVICE OPERATED WITHIN SPECIFICATION. THE ALLEGATION WAS NOT CONFIRMED. 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 TEST WAS PERFORMED AND PASSED. PAIRING TEST WAS PERFORMED AND PASSED. A REVIEW OF THE SHARE LOGS WAS PERFORMED AND SIGNAL LOSS WAS FOUND WITHIN THE INVESTIGATION WINDOW. HOWEVER, THE DEVICE OPERATED WITHIN SPECIFICATION. THE ALLEGATION WAS NOT CONFIRMED. 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 |
|---|---|---|---|---|---|---|---|
| 2388506 | DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | QBJ | DEXCOM, INC. | 9445-24 | P12948137 | 00386270001788 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Female |