The Department of Health (DH) today (April 30) drew public attention to a safety alert concerning a glucose test strip called GenStrip Blood Glucose Test Strips. The test strip, manufactured and sold by Shasta Technologies LLC, may report incorrect blood glucose readings.
The DH, through its routine surveillance on medical devices, noticed the above alert issued by the US Food and Drug Administration (FDA). The test strips concerned are advertised for use with the LifeScan OneTouch family of glucose meters (e.g. Ultra, Ultra 2 and Ultra Mini) manufactured by another medical device manufacturer, Johnson and Johnson.
According to the alert, the FDA found extensive violations of relevant regulations intended to assure the quality of products in the manufacturing of the test strips during a recent inspection of Shasta Technologies LLC. As the company did not have in place many of the requirements of a quality system, the FDA believes that the strips could report incorrect blood glucose levels.
A spokesman for the DH explained that false blood glucose readings may mislead a diabetic patient into inappropriate management of his or her condition, resulting in hypoglycaemia or hyperglycemia.
The DH is investigating whether GenStrip Blood Glucose Test Strips have been imported into Hong Kong. As the LifeScan OneTouch family of glucose meters is available for sale locally, there is also a possibility that some patients may have purchased the affected test strips abroad or from the Internet for their own use. The DH hence advises the public to stop using the product concerned and switch to alternative blood glucose test strips which are designed for use with the LifeScan OneTouch family of glucose meters.
So far, the DH has not received any local report of adverse events arising from use of the product.
The DH, through its routine surveillance on medical devices, noticed the above alert issued by the US Food and Drug Administration (FDA). The test strips concerned are advertised for use with the LifeScan OneTouch family of glucose meters (e.g. Ultra, Ultra 2 and Ultra Mini) manufactured by another medical device manufacturer, Johnson and Johnson.
According to the alert, the FDA found extensive violations of relevant regulations intended to assure the quality of products in the manufacturing of the test strips during a recent inspection of Shasta Technologies LLC. As the company did not have in place many of the requirements of a quality system, the FDA believes that the strips could report incorrect blood glucose levels.
A spokesman for the DH explained that false blood glucose readings may mislead a diabetic patient into inappropriate management of his or her condition, resulting in hypoglycaemia or hyperglycemia.
The DH is investigating whether GenStrip Blood Glucose Test Strips have been imported into Hong Kong. As the LifeScan OneTouch family of glucose meters is available for sale locally, there is also a possibility that some patients may have purchased the affected test strips abroad or from the Internet for their own use. The DH hence advises the public to stop using the product concerned and switch to alternative blood glucose test strips which are designed for use with the LifeScan OneTouch family of glucose meters.
So far, the DH has not received any local report of adverse events arising from use of the product.
Reprinted from HKSAR Government:
http://www.info.gov.hk/gia/general/201404/30/P201404300777.htm