The Department of Health was notified by the Food and Drug Administration of the United States today (September 11) about a worldwide medical device alert on a type of blood glucose meter with a display screen which may not work properly when dropped onto a hard surface.
A department spokesman said the alert was initiated by the manufacturer, Abbott Diabetes Care, involving blood glucose meters manufactured after January, 2007.
The display screen of the affected meters, marked as "Abbott Optium Xceed", may not work properly or may appear blank if dropped on a hard surface. This means users will be unable to view the blood glucose test results.
It was revealed that 857 affected devices were sold in Hong Kong but none of them were released to hospitals.
As a precautionary measure, users should not use the blood glucose monitor if the display shows a missing or blank section. They should contact the local agent or supplier for replacement.
"Users should ensure a full display show each time the blood glucose monitor is turned on, especially before using the monitor to check the blood glucose level," the spokesman said.
The spokesman said the department had alerted the Hospital Authority, private hospitals, nursing homes and medical professional associations to this medical device correction.
The department has not received any report of adverse events arising from this issue.
The spokesman said people using the meters concerned should contact the local agent by calling its hotline 2806 4488 during office hours for advice.
Relevant information is available at the manufacturer's website at
http://www.abbottdiabetescare.com/adc_dotcom/url/content/en_US/
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Reprinted from HKSAR Government web page:
http://www.info.gov.hk/gia/general/200709/11/P200709110213.htm