martes, 12 de abril de 2016

G4 Platinum and G5 Mobile Continuous Glucose Monitoring System Receivers by Dexcom: Class I Recall - Audible Alarm Failure

AUDIENCE: Risk Manager, Health Professional, Patient

ISSUE: Dexcom Inc. is recalling the Continuous Glucose Monitoring Systems because the audible alarm may not activate in the receiver piece when low or high glucose levels (hypoglycemia or hyperglycemia) are detected. Relying on this product for notification of low or high blood sugar could result in serious adverse consequences, including death as the auditory alarm may not sound and users might not be notified of low or high blood sugar.

Recalled Devices include (all model numbers and all lot numbers): Dexcom G4 PLATINUM Receiver, Dexcom G4 PLATINUM (Pediatric) Receive, Dexcom G4 PLATINUM (Professional) Receiver, Dexcom G4 PLATINUM Receiver with Share, Dexcom G4 PLATINUM (Pediatric) Receiver with Share, Dexcom G5 Mobile Receiver.

BACKGROUND: The Dexcom Continuous Glucose Monitoring Systems are used to monitor the blood sugar (glucose) level of adult and pediatric patients with type 1 or type 2 diabetes. These glucose monitoring systems include a sensor that is placed under the skin to measure blood glucose readings that are sent to a hand-held receiver. They are used in combination with standard home glucose monitoring devices in the management of diabetes.

RECOMMENDATION: On February 23, 2016, Dexcom Inc. sent an Important Customer Notification Letter with the following instructions to test the audio alert on the receiver:

press the center button on your receiver to access the Main Menu
scroll down to Profiles
select Profiles
scroll down to Try It
select Try It
scroll down to 55 Fixed Low
select 55 Fixed Low
verify that you receive vibrations first (vibratory portion of alarm), followed by beeps (audible portion of alarm).

Customers should contact Dexcom at their free hotline number: (844) 607-8398, if the audio alert does not work properly.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including links to the Class I Recall notice, athttp://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm495468.htm

You are subscribed to MedWatch Safety Alerts for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.

You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm