The Department of Health (DH) today (January 20) drew the public's attention to a safety alert issued by the United States Food and Drug Administration on a voluntary recall by Tandem Diabetes Care, an American medical device manufacturer, over its insulin cartridges of t:slim Insulin Pump as they may be at risk of leakage.
The DH noticed the alert through its routine surveillance on medical devices. According to Tandem, leakage of cartridges of the affected lots (see Attachment) could deliver too much or too little insulin, a hormone for control of blood glucose levels, which can lead to a serious adverse event during the management of patients with diabetes mellitus.
According to information provided by Tandem, no adverse events have been reported to date. The affected lots of 4 746 boxes of cartridges (10 cartridges per box) were shipped on or after December 17, 2013.
"We are maintaining liaison with the manufacturer to ascertain if the affected lots have been distributed in Hong Kong," a spokesman for the DH remarked.
"Members of the public in possession of the affected product should stop using it immediately. Those who feel sick after using it or are in doubt should consult their health-care professionals promptly," the spokesman said.
Ends/Monday, January 20, 2014
Issued at HKT 20:07