FDA Adverse Event Malfunction Summary report: N

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

MDR report key: 10721838 · Received October 22, 2020

Report

Report Number: 3004753838-2020-124231
Event Type: Malfunction
Date Received: October 22, 2020
Date of Event: September 23, 2020
Report Date: December 7, 2020
Manufacturer: DEXCOM, INC.
Product Code: QBJ
UDI-DI: 00386270000385
PMA / PMN Number: DEN170088
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: PA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

COM-1961309-20. B5: DESCRIBE EVENT OR PROBLEM - ADDITIONAL. D4: ADDITIONAL DEVICE INFORMATION - ADDITIONAL. D10: DEVICE AVAILABLE FOR EVALUATION- ADDITIONAL . H2: ADDITIONAL INFORMATION/DEVICE EVALUATION. H3: DEVICE EVALUATED BY MANUFACTURER - ADDITIONAL. H6: EVENT PROBLEM AND EVALUATION CODES - ADDITIONAL.

Description of Event or Problem · 0

IT WAS REPORTED THAT SIGNAL LOSS OVER ONE HOUR OCCURRED. THE PRODUCT WAS EVALUATED. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. TRANSMITTER VOLTAGE TEST WAS PERFORMED AND PASSED DUE TO (0.21 VDC). NORDIC BLUETOOTH PAIRING TEST WAS PERFORMED AND PASSED. A REVIEW OF THE SHARE LOGS WAS PERFORMED AND SIGNAL LOSS WAS NOT FOUND WITHIN THE INVESTIGATION WINDOW. THE ALLEGATION WAS NOT CONFIRMED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

Additional Manufacturer Narrative · 1

(B)(4).

Description of Event or Problem · 1

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
1186887	DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM	CONTINUOUS GLUCOSE MONITOR	QBJ	DEXCOM, INC.	9445-02	7270539	00386270000385

Patients

Seq	Age	Sex	Outcome	Treatment
1	56 YR