FDA Adverse Event Injury Summary report: N

DEXCOM G6 CONTINUOUS GLUCOSE MONITOR

MDR report key: 10179855 · Received June 19, 2020

Report

Report Number
MW5095134
Event Type
Injury
Date Received
June 19, 2020
Date of Event
June 10, 2020
Report Date
June 18, 2020
Manufacturer
DEXCOM, INC.
Product Code
QBJ
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
VT, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

I HAVE BEEN WEARING THE DEXCOM G6 CGM SINCE JANUARY OF THIS YEAR WITHOUT AN ISSUE. UNTIL I REC'D MY SECOND ORDER OF THE CGM SENSORS. SINCE THE END OF MAY I HAVE EXPERIENCED ITCHING UPON PLACING THE G6 SENSOR ON MY STOMACH FROM THE ADHESIVE. UPON REMOVING THE CGM 10 DAYS LATER I HAVE A BLISTERING 2X3 INCH RASH. I CHECKED THE FAQS FOR EXPERIENCING A BAD REACTION ON THE DEXCOM SITE AND AS A PREVENTATIVE APPLIED AN IV 3000 BARRIER FILM ON MY SKIN AND THEN PLACED A NEW SENSOR ON THAT. HOWEVER I HAD TO REMOVE THE SECOND SENSOR EARLIER THAN 10 DAYS AND WHEN I DID I HAD ANOTHER RED RASH 2X3 RASH. I CALLED DEXCOM TODAY TO REPORT THIS AND THE CUSTOMER SUPPORT PERSON WAS A TERRIBLE LISTENER AS I STARTED BY TELLING HIM MY BAD SENSOR ADHESIVE EXPERIENCE AND THAT I HAD BEEN SEEN BY MY ENDOCRINOLOGIST (WHO COULD NOT BELIEVE THE BLISTERING RASH I HAVE), HAVE BEEN PLACED ON BOTH AN ANTIBIOTIC AND BETAMETHASONE VALER 0.1% OINTM OINTMENT CREAM. I TOLD THE CUSTOMER SERVICE REP THAT I READ THE FAQS ON THE DEXCOM SITE. BUT AS IS TYPICAL, HE WAS NOT LISTENING, HE DIRECTED ME TO THE FAQ DOCUMENT AND TO MY ENDOCRINOLOGIST. FINALLY I GOT HIM TO UNDERSTAND THAT I WAS CALLING TO REPORT MY ADVERSE REACTION TO THE SENSOR ADHESIVE. HE TOOK THE LOT NUMBER FROM THE SENSOR BOX AND OPENED A CASE. I PRESSED HIM ON IF DEXCOM HAD CHANGED THE ADHESIVE AND HE SAID YES THERE HAD BEEN A SLIGHT CHANGE RECENTLY. I THEN PRESSED HIM IF MY FEEDBACK WOULD BE SHARED WITH THE PRODUCT TEAM AND HE RESPONDED THAT HE HAD OPENED A CASE BUT WOULD NOT SAY WHO REVIEWS THE CASES OR HOW OFTEN. THIS IS REALLY FRUSTRATING BECAUSE I HAD NO ISSUES UNTIL THE LAST 2 CGM SENSORS. (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
637831 DEXCOM G6 CONTINUOUS GLUCOSE MONITOR INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED QBJ DEXCOM, INC. G6 52711848
637832 SENSORS SENSOR, GLUCOSE, INVASIVE MDS DEXCOM, INC.
637833 SENSORS SENSOR, GLUCOSE, INVASIVE MDS DEXCOM, INC.

Patients

Seq Age Sex Outcome Treatment
1 56 YR Other| R