G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

MDR report key: 3924228 · Received July 9, 2014

Report

Report Number: 3004753838-2014-04937
Event Type: Malfunction
Date Received: July 9, 2014
Date of Event: June 14, 2014
Report Date: June 14, 2014
Manufacturer: DEXCOM, INC.
Product Code: MDS
PMA / PMN Number: P120005
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

(B)(4).

Additional Manufacturer Narrative · 1

(B)(4). EVALUATION OF THE RETURNED DEVICE AND REVIEW OF THE DATA LOG DID NOT CONFIRM THE REPORTED INTERMITTENT AUDIO OUTPUT.

Description of Event or Problem · 1

PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 TO CLAIM INTERMITTENT AUDIO OUTPUT ON (B)(6) 2014 RESULTED IN A HYPOGLYCEMIC EVENT ON THE SAME DATE. PATIENT CLAIMED THAT WHILE EATING LUNCH, FELT UNWELL. PATIENT THEN CLAIMED RECEIVER DID NOT SHOW A NUMBER, JUST INDICATED LOW. PATIENT ADVISED OF NOT TAKING A FINGER STICK READING, BUT STATED THAT JUICE WAS SELF ADMINISTERED. PATIENT STATED A NEIGHBOR CONTACTED PARAMEDICS. PATIENT CLAIMED PARAMEDICS ARRIVED ON THE SCENE AND TOOK FINGER STICK READING. IN ADDITION, PATIENT CLAIMED PARAMEDICS PROVIDED JUICE AND REMAINED UNTIL PATIENT'S BLOOD SUGAR WAS ELEVATED ENOUGH TO LEAVE. PATIENT ADVISED DEXCOM TECHNICAL SUPPORT THAT NO HOSPITALIZATION WAS NECESSARY. AT THE TIME OF THE CALL TO DEXCOM TECHNICAL SUPPORT, NO OTHER MEDICAL INTERVENTION OR INJURIES WERE REPORTED. PATIENT REPORTED AT THE END OF THE CALL WITH DEXCOM TECHNICAL SUPPORT THAT PATIENT WAS DOING BETTER NOW. DEXCOM HAS ISSUED AN RGA FOR PATIENT TO RETURN THE DEVICE TO BE INVESTIGATED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
399925	G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM	MDS	MDS	DEXCOM, INC.	MT20649

Patients

Seq	Age	Sex	Outcome	Treatment
1	59 YR		Other