FDA Adverse Event Malfunction Summary report: N

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

MDR report key: 10838683 · Received November 13, 2020

Report

Report Number: 3004753838-2020-136285
Event Type: Malfunction
Date Received: November 13, 2020
Date of Event: October 6, 2020
Report Date: January 9, 2021
Manufacturer: DEXCOM, INC.
Product Code: QBJ
UDI-DI: 00386270000385
PMA / PMN Number: DEN170088
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NC, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

(B)(4). B5: DESCRIBE EVENT OR PROBLEM - ADDITIONAL INFORMATION. D9: DEVICE AVAILABILITY - ADDITIONAL INFORMATION. H2: ADDITIONAL INFORMATION/ DEVICE EVALUATION/ CORRECTION. H3: DEVICE EVALUATED BY MANUFACTURER- ADDITIONAL INFORMATION. H6: ADVERSE EVENT PROBLEM - ADDITIONAL INFORMATION/ CORRECTION - OMIT CODE 4112, 114, 3227, 4307 FROM INITIAL SUBMISSION.

Description of Event or Problem · 0

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 DUE TO 0V. NO DATA WAS PROVIDED FOR EVALUATION. CONFIRMATION OF THE ALLEGATION WAS UNDETERMINED. 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 TRANSMITTER FAILED ERROR 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
1303211	DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM	CONTINUOUS GLUCOSE MONITOR	QBJ	DEXCOM, INC.	9445-02	5277365	00386270000385

Patients

Seq	Age	Sex	Outcome	Treatment
1	56 YR