DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

MDR report key: 5334287 · Received December 30, 2015

Report

Report Number: 3004753838-2015-78189
Event Type: Malfunction
Date Received: December 30, 2015
Date of Event: December 3, 2015
Report Date: December 3, 2015
Manufacturer: DEXCOM, INC.
Product Code: MDS
UDI-DI: 00386270000125
PMA / PMN Number: P120005
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(6).

Additional Manufacturer Narrative · 1

(B)(4).

Description of Event or Problem · 1

PATIENT CONTACTED DEXCOM ON (B)(6) 2015 TO REPORT THAT ON (B)(6) 2015, THE PATIENT EXPERIENCED AN INTERMITTENT OUT OF RANGE SIGNAL. 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.

Description of Event or Problem · 1

SUBSEQUENT TO THE INITIAL MDR, THE COMPLAINT TRANSMITTER WAS NOT RETURNED TO DEXCOM. THE RECEIVER (PART NUMBER STK-DR-001/SERIAL NUMBER (B)(4)/LOT NUMBER 5203264), BEING USED WITH THE COMPLAINT TRANSMITTER, WAS RETURNED ON (B)(4) 2015. THE RETURNED RECEIVER WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. FUNCTIONAL TESTING WAS PERFORMED AND THE REPORTED FAULT COULD NOT BE REPRODUCED AND THERE WAS NO FAILURE DETECTED. THE DEVICE WAS DETERMINED TO BE OPERATING WITHIN THE REQUIRED SPECIFICATIONS WITHOUT MALFUNCTION; HOWEVER, A REVIEW OF THE DOWNLOADED RECEIVER LOG CONFIRMED THE REPORTED EVENT OF AN INTERMITTENT OUT OF RANGE SIGNAL. A ROOT CAUSE COULD NOT BE DETERMINED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
860123	DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM	MDS	MDS	DEXCOM, INC.	9438-05	5203780	00386270000125

Patients

Seq	Age	Sex	Outcome	Treatment
1	25 YR