DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
Report
- Report Number
- 3004753838-2022-140117
- Event Type
- Malfunction
- Date Received
- August 3, 2022
- Date of Event
- July 25, 2022
- Report Date
- November 3, 2022
- Manufacturer
- DEXCOM, INC.
- Product Code
- QBJ
- UDI-DI
- 00386270001627
- PMA / PMN Number
- DEN170088
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(B)(4).
(B)(4). B5: DESCRIBE EVENT OR PROBLEM ADDITIONAL INFORMATION . D9: DEVICE RETURNED TO MFR ADDITIONAL INFORMATION. D9: DATE DEVICE RETURNED ADDITIONAL INFORMATION. H2 TYPE OF FOLLOW UP: ADDITIONAL INFORMATION/ DEVICE EVALUATION. H3A: DEVICE EVALUATED BY MFG ADDITIONAL INFORMATION. H3B: EVALUATION INCLUDED ADDITIONAL INFORMATION. H6: ADDITIONAL INFORMATION.
(B)(4). THIS MDR WAS PREVIOUSLY SUBMITTED ON 09/21/2022 WITH MFR# 3004753838-2022-140117-01. THE ACK2 WAS RECEIVED ON 09/21/2022 BY CDRH WITH COREID: (B)(4). 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. DUE TO MULTIPLE ATTEMPTS OF SUBMITTING THIS MDR USING FOLLOW-UP "01" BUT IT CONTINUES IN FAILING DUE TO DUPLICATE, WE VERIFY IN THE FDA WEBSITE HTTPS://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDRH/CFDOCS/CFMAUDE/SEARCH.CFM BUT THERE ARE NO RECORDS FOUND WITH REPORT NUMBER: 3004753838-2022-140117-01 THEREFORE WE'RE SUBMITTING THIS SUPPLEMENTAL AS FOLLOW-UP "02".
IT WAS REPORTED THAT TRANSMITTER FAILED ERROR OCCURRED. 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.
IT WAS REPORTED THAT TRANSMITTER FAILED ERROR OCCURRED. THE PRODUCT WAS EVALUATED. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. VOLTAGE TEST 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 TRANSMITTER FAILED ERROR OCCURRED. THE PRODUCT WAS EVALUATED. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. VOLTAGE TEST 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2163268 | DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | QBJ | DEXCOM, INC. | 9445-24 | 5309415 | 00386270001627 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Female |