DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM

MDR report key: 5325765 · Received December 23, 2015

Report

Report Number: 3004753838-2015-74542
Event Type: Malfunction
Date Received: December 23, 2015
Date of Event: December 2, 2015
Report Date: December 2, 2015
Manufacturer: DEXCOM, INC.
Product Code: MDS
UDI-DI: 00386270000156
PMA / PMN Number: P120005
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: UT, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4).

Additional Manufacturer Narrative · 1

(B)(4).

Description of Event or Problem · 1

THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. A REVIEW OF THE DOWNLOADED RECEIVER LOG CONFIRMED THE REPORTED EVENT OF A FIRMWARE ERROR. A ROOT CAUSE COULD NTO BE DETERMINED. THE DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM REV. 11, UNDER SECTION 13.8.2 RECEIVER ERROR CODE NOTES THE FOLLOWING: THIS SCREEN SHOWS AN ERROR CODE THAT MEANS THE RECEIVER MAY NOT BE WORKING PROPERLY. WRITE DOWN THE ERROR CODE AND CONTACT DEXCOM TECHNICAL SUPPORT. CONTINUE TO CHECK YOUR BLOOD GLUCOSE VALUE USING YOUR BLOOD GLUCOSE METER. NO ALERT SOUND OR VIBRATION WILL WARN YOU THAT YOU ARE NO LONGER GETTING SENSOR GLUCOSE READINGS.

Description of Event or Problem · 1

PATIENT CONTACTED DEXCOM ON (B)(6) 2015 TO REPORT THAT THE RECEIVER DISPLAYED A FIRMWARE ERROR ON (B)(6) 2015. THE PATIENT DID NOT REPORT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. THE DEVICE HAS BEEN RECEIVED FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
848208	DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM	MDS	MDS	DEXCOM, INC.	MT22495	5205009	00386270000156

Patients

Seq	Age	Sex	Outcome	Treatment
1	69 YR