DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

MDR report key: 5211645 · Received November 9, 2015

Report

Report Number: 3004753838-2015-62992
Event Type: Malfunction
Date Received: November 9, 2015
Date of Event: October 18, 2015
Report Date: October 18, 2015
Manufacturer: DEXCOM, INC.
Product Code: MDS
UDI-DI: 00386270000125
PMA / PMN Number: P120005
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TX, 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 TRANSMITTER WAS NOT RETURNED TO DEXCOM. THE RECEIVER (PART NUMBER STK-PR-PNK/SERIAL NUMBER (B)(4)/LOT NUMBER 5201273), 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 DIAGNOSTIC CHART CONFIRMED THE REPORTED EVENT OF AN INTERMITTENT OUT OF RANGE SIGNAL. A ROOT CAUSE COULD NOT BE DETERMINED.

Description of Event or Problem · 1

PATIENT'S MOTHER CONTACTED DEXCOM ON (B)(6) 2015 TO REPORT THAT ON (B)(6) 2015, PATIENT EXPERIENCED AN INTERMITTENT OUT OF RANGE SIGNAL. THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION. HOWEVER, THE DATA LOG WAS PROVIDED BY THE PATIENT. THE DATA WAS REVIEWED AND DID NOT CONFIRM THE REPORTED EVENT OF INTERMITTENT ANTENNA ICON. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
742045	DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM	MDS	MDS	DEXCOM, INC.	9438-05	5203773	00386270000125

Patients

Seq	Age	Sex	Outcome	Treatment
1	7 YR