Contour and Contour TS Glucose Test Strips 의 안전성 경고

Safety alert

2011-08-16

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/press_20110817.html

Recall of bayer's contour and contour ts glucose test strips the department of health (dh) today (august 16) directs a local medical device supplier, bayer healthcare limited (bayer), to recall from consumers all batches of its two products, namely contour and contour ts glucose test strips, as ongoing in-house quality assurance scheme by the manufacturer has detected the production of erroneously low blood glucose readings. since the consequential hyperglycaemia in users may pose dreaded and even fatal health risks, the recall is therefore a necessity for safeguarding public health . bayer reports to dh that the issue came to light when the manufacturer, bayer healthcare diabetes, found on routine testing that strips from half of the bottles of 5s, 10s and 25s produced falsely low blood glucose readings.  in-house investigation findings so far point to interaction of the strips with the gas trapped inside the bottles as the cause of the defect. "given that so far there is no indication that the strip and the packing method for each of the four package sizes is unique and not identical, and the lack of a satisfactory explanation for the sparing of the 50-unit bottles, dh considers it only prudent to advise for a blanket recall of all four package sizes, the 50-unit one included.  the recall scope will be reviewed on availability of new evidence," a dh spokesman explains. "that dh is also advising the recall of contour although bayer only sold contour ts in hong kong is because as the manufacturer has already found out that the former is affected as well and given the high prevalence of diabetes mellitus worldwide, international travellers included, plus the popularity of internet sales, we consider the inclusion of contour test strip as an integral element of a global control effort," the spokesman elaborates. indeed, bayer's sales record shows that contour ts has been sold to public and private hospitals, private practitioners and also retailers.  in connection, dh has informed the hospital authority, all private hospitals and nursing homes.  it is understood that bayer has set up phone hotlines at 2814 5121 and 2814 4846 for handling enquiries. "so far, there is no evidence to suggest that bayer's other glucose test strips, including that for use with the breeze 2 meter on sale locally, are affected.  moreover, no related adverse incident report has been received either here or worldwide.  however, dh will continue to investigate, including working with overseas counterparts, for both the cause and the scope," the spokesman emphasizes. "consumers are advised to switch to unaffected options in the market for blood glucose monitoring.  however, pending the availability of an alternative in hand, consumers must not discontinue monitoring with any of the affected strips as the risk of not monitoring their blood glucose may outweigh erroneously low  blood glucose readings obtained under the present circumstances.  in any case, they ought to consult their healthcare providers for switching advice, or whenever in doubt or feel unwell," the spokesman urges.