DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
Report
- Report Number
- 3004753838-2022-052341
- Event Type
- Malfunction
- Date Received
- April 4, 2022
- Date of Event
- March 9, 2022
- Report Date
- April 4, 2022
- Manufacturer
- DEXCOM, INC.
- Product Code
- QBJ
- PMA / PMN Number
- DEN170088
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
(B)(4).
SKIP TO NAVIGATIONSKIP TO MAIN CONTENT COMPLAINTS COMPLAINTS PRESS SPACEBAR TO REORDER. HOME TASKS COMPLAINTS MEDICAL REVIEWS MDRS MIRS COMPLAINT COMPLAINT CMPL-(B)(4) PATH ATTACHMENTS NO ATTACHMENTS AVAILABLE! TABS DETAILS NO OF DAYS FOR DECISION TREENO OF DAYS FOR DECISION TREE 0 DT COMPLETION DATEDT COMPLETION DATE (B)(6) 2022 COMPLAINT NOCOMPLAINT NO (B)(4) CLASSIFICATION CODECLASSIFICATION CODE 115 CLASSIFICATION CODE DESCRIPTIONCLASSIFICATION CODE DESCRIPTION LOSS OF CONNECTION SOURCESOURCE PHONE OSVC ID NUMBEROSVC ID NUMBER 9063354 OSVC REFERENCE NUMBEROSVC REFERENCE NUMBER 220309-002789 OSVC CREATED BYOSVC CREATED BY AZE0720 RECORD CATEGORYRECORD CATEGORY COMPLAINT REGIONREGION NORTH AMERICA GROUPGROUP NORTH AMERICA - 115 PSRPSR PSR OWNEROWNER RUBY ASPERA STATUSSTATUS COMPLAINT REVIEW COMPLETE RECORD TYPERECORD TYPE COMPLAINT PENDING MEDICAL REVIEWPENDING MEDICAL REVIEW PENDING MEDICAL REVIEW PENDING DECISION TREESPENDING DECISION TREES PENDING DECISION TREES PENDING DEV INVESTIGATIONPENDING DEV INVESTIGATION PENDING DEV INVESTIGATION PENDING HARPENDING HAR PENDING HAR PENDING UPDATE REQUESTPENDING UPDATE REQUEST PENDING UPDATE REQUEST UPDATE REQUEST STATUSUPDATE REQUEST STATUS NO UPDATE REQUEST COUNTRY OF PURCHASECOUNTRY OF PURCHASE UNITED STATES COUNTRY OF INCIDENTCOUNTRY OF INCIDENT UNITED STATES CITY OF INCIDENTCITY OF INCIDENT NA REPORTER ORGANIZATIONREPORTER ORGANIZATION NA DISTRIBUTOR UNIQUE COMPLAINT NO (DUCN)DISTRIBUTOR UNIQUE COMPLAINT NO (DUCN) NA DISTRIBUTOR COMPLAINT DATEDISTRIBUTOR COMPLAINT DATE FILES ADDED TO COMPLAINTFILES ADDED TO COMPLAINT FILE NAME: CMPL-(B)(4) GAP CONFIRMED 467.FILE NAME: CMPL-(B)(4) PLOT.PNG PATIENT BIRTHDATEPATIENT BIRTHDATE (B)(6) 1952 PATIENT WEIGHTPATIENT WEIGHT 200 LBS AGE AT THE TIME OF EVENTAGE AT THE TIME OF EVENT 70 REPORTER TYPEREPORTER TYPE PATIENT PEDIATRIC OR ADULTPEDIATRIC OR ADULT ADULT AGE UNITAGE UNIT YEARS SERIOUS ADVERSE EVENT INFORMATION (0) EVENT DESCRIPTIONEVENT DESCRIPTION PATIENT REPORTED SIGNAL LOSS OVER 1 HOUR CONCLUSIONCONCLUSION NO TX REPLACEMENT SENT PT WILL UNINSTALL/REINSTALL THE APP THEN WILL REBOOT HIS PHONE IF ISSUE STILL PERSIST PT WILL CALLBACK SO THAT WE CAN PROCESS NECESSARY REPLACEMENT/S NOTE: IF PT CALLS BACK PLEASE ASSIST AND PROCESS A REPLACEMENT FOR THE TX AND SENSOR AND RGA ALERT DATEALERT DATE (B)(6) 2022 EVENT DATEEVENT DATE (B)(6) 2022 DATE SENSOR INSERTED/APPLIEDDATE SENSOR INSERTED/APPLIED WAS IFU FOLLOWED?WAS IFU FOLLOWED? NA PATIENT TOOK APAP/ACETAMINOPHEN?PATIENT TOOK APAP/ACETAMINOPHEN? NA NO OF DAYS SINCE OPENEDNO OF DAYS SINCE OPENED 26 DOWNLOAD IDENTIFIER 8SA1T1 TYPE DOWNLOAD IDENTIFIER TYPE TRANSMITTER IS PATIENT USING A RECEIVER,MOBILE,BOTH?IS PATIENT USING A RECEIVER,MOBILE,BOTH? SMART DEVICE IS THE DATE EXACT OR APPROXIMATE?IS THE DATE EXACT OR APPROXIMATE? EXACT INSERTION SITEINSERTION SITE NA DEATH REPORTEDDEATH REPORTED DEATH REPORTED DATE OF DEATHDATE OF DEATH MEDICAL INTERVENTION/SERIOUS INJURYMEDICAL INTERVENTION/SERIOUS INJURY MEDICAL INTERVENTION/SERIOUS INJURY RGA CREATED?RGA CREATED? NO,THE PRODUCT ISN'T ABLE TO BE RETURNED RGA REFERENCE NUMBERRGA REFERENCE NUMBER NA NO RGA JUSTIFICATIONNO RGA JUSTIFICATION RESOLVED IN TROUBLESHOOTING/KEPT PRODUCT RGA FOLLOW UP COMPLETED?RGA FOLLOW UP COMPLETED? NOT APPLICABLE TROUBLESHOOTING QUESTIONS (6+) NAVIGATION MODE PQ NO QUESTION ANSWER PQ-(B)(4) IS THE PATIENT USING ANY OTHER BLUETOOTH ACCESSORIES AT THE TIME OF SIGNAL LOSS? NO PQ-(B)(4) WAS THE PATIENT'S TRANSMITTER SUCCESSFULLY PAIRED TO THE RECEIVER OR SMART DEVICE PRIOR TO SIGNAL LOSS? YES PQ-(B)(4) TRANSMITTER WARRANTY EXPIRATION DATE 2022-04-27 PQ-(B)(4). WHAT WAS DISPLAYED BEFORE? SIGNAL LOSS PQ-(B)(4). DID THE SIGNAL RETURN OR IS SIGNAL LOSS STILL DISPLAYED? SIGNAL LOSS IS STILL DISPLAYED PQ-(B)(4). WHAT DEVICE(S) ARE DISPLAYING THE SIGNAL LOSS? SMART DEVICE VIEW ALLTROUBLESHOOTING QUESTIONS PRODUCT LINEPRODUCT LINE STT-OR-001 PRODUCT LINE DESCRIPTION PRODUCT LINE DESCRIPTION G6 TRANSMITTER KIT, DEXCOM TRANSMITTER SUB-COMPONENT TRANSMITTER SUB-COMPONENT G6 TRANSMITTER: 9445-24 RECEIVER SERIAL NUMBER RECEIVER SERIAL NUMBER NA PRODUCT GENERATION PRODUCT GENERATION G6 LOT NUMBER LOT NUMBER 5293283 NCMR DETAILSNCMR DETAILS NO NCMRS ASSOCIATED WITH THE PRODUCT MANUFACTURING DATE MANUFACTURING DATE (B)(6) 2021 EXPIRATION DATE EXPIRATION DATE (B)(6) 2022 TRANSMITTER SERIAL NUMBER TRANSMITTER SERIAL NUMBER (B)(4) CATEGORYCATEGORY TRANSMITTER PRODUCT REGISTRATIONPRODUCT REGISTRATION STT-OR-001 ADDITIONAL PRODUCT INFORMATION (0) DATA ANALYSIS SUMMARYDATA ANALYSIS SUMMARY DATA INVESTIGATION CONFIRMED LOSS OF CONNECTION ON (B)(6) 2022. ALLEGATION CONFIRMED BY DATAALLEGATION CONFIRMED BY DATA CONFIRMED DATA ANALYSIS STATUSDATA ANALYSIS STATUS COMPLETED - MANUAL PLATFORM DATA SOURCEPLATFORM DATA SOURCE ANDROID APP G6 DATA AVAILABLE?DATA AVAILABLE? YES MANUFACTURER'S NARRATIVE (B5)MANUFACTURER'S NARRATIVE (B5) IT WAS REPORTED THAT SIGNAL LOSS OVER ONE HOUR OCCURRED. A REVIEW OF THE SHARE LOGS WAS PERFORMED AND SIGNAL LOSS WAS FOUND WITHIN THE INVESTIGATION WINDOW. THE ALLEGATION WAS CONFIRMED. THE PROBABLE CAUSE WAS THE TRANSMITTER AND APP WERE UNABLE TO ESTABLISH A CONNECTION. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 500407 | DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | QBJ | DEXCOM, INC. | 9445-24 | 5293283 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Male |