FDA Adverse Event Injury Summary report: N

T:SLIM G5 SYSTEM

MDR report key: 7274702 · Received February 15, 2018

Report

Report Number: 3013756811-2018-05284
Event Type: Injury
Date Received: February 15, 2018
Date of Event: January 26, 2018
Report Date: February 15, 2018
Manufacturer: DEXCOM, INC.
Product Code: OYC
PMA / PMN Number: P140015
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

THE T:SLIM X2 USER GUIDE STATES, ¿CALIBRATE YOUR CGM AT LEAST ONCE EVERY 12 HOURS. CALIBRATING LESS OFTEN THAN EVERY 12 HOURS MIGHT CAUSE SENSOR GLUCOSE READINGS TO BE INACCURATE AND GLUCOSE ALERTS TO BECOME UNRELIABLE. THIS COULD RESULT IN YOU MISSING SEVERE HYPOGLYCEMIA (LOW BLOOD GLUCOSE) OR HYPERGLYCEMIA (HIGH BLOOD GLUCOSE) EVENTS.¿ NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. DEVICE NOT RETURNED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THERE WAS MULTIPLE INACCURACIES BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) READING AND THE BLOOD GLUCOSE (BG) METER READING. REPORTEDLY, THE CGM BG READING WAS 123-378 MG/DL, AND THE METER BG READING WAS 86-289 MG/DL. REPORTEDLY, THE CUSTOMER WAS NOT PERFORMING A CALIBRATION EVERY 12 HOURS. IN ADDITION, IT WAS REPORTED THAT THE CUSTOMER'S BG LEVEL DROPPED TO 40 MG/DL DUE TO INACCURATE BG READINGS. REPORTEDLY, THE CUSTOMER REQUIRED ASSISTANCE WITH ADDRESSING LOW BG LEVELS. FOOD AND JUICE WAS BROUGHT TO THE CUSTOMER TO TREAT LOW BG'S. A REPLACEMENT SENSOR WAS SENT TO THE CUSTOMER.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
116987	T:SLIM G5 SYSTEM	CONTINUOUS GLUCOSE MONITOR	OYC	DEXCOM, INC.	9500-27	5230772

Patients

Seq	Age	Sex	Outcome	Treatment
1	62 YR		Required Intervention