G4 PLATINUM and Dexcom G5 Mobile receiver 의 안전성 경고

Safety alert

2016-03-09

2016-03-09

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20160309b.html

Medical device safety alert: dexcom g4 platinum and dexcom g5 mobile receiver the therapeutic goods administration (tga) of australia has posted a medical device safety alert concerning dexcom g4 platinum and dexcom g5 mobile receiver manufactured by dexcom incorporated. [part number: mt20649-2 and mt22719-2]. the manufacturer has noticed an increase in complaints related to audible alarms and alerts associated with dexcom g4 platinum and dexcom g5 receivers while monitoring product complaints through their quality management system. the manufacturer is notifying all affected customers that they may not receive an intended audible alarm or alert. as a result, if they rely on hearing the alarm or alert, they may not detect a severe hypoglycaemic (low glucose) or hyperglycaemic (high glucose) event. this includes the fixed low alarm at 3.1 mmol/l, which alerts the user with vibration first, followed by beeps 5 minutes later if not confirmed. the vibration alert should continue to work; however, the audible beeps may not function. the vibration function for the alerts and alarm cannot be disabled by the user. the manufacturer is providing users with instructions on how to test the audible alarms to ensure they are functioning properly. according to the local supplier, dexcom g4 platinum is distributed in hong kong but not dexcom g5 mobile receiver. for details, please refer to the tga website: http://apps.Tga.Gov.Au/prod/sara/arn-detail.Aspx?k=rc-2016-rn-00224-1 if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 9 march 2016.