CoaguChek blood coagulation testing devices 의 안전성 경고

Safety alert

2013-05-06

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/press_20130506.html

Safety alert on coaguchek blood coagulation testing devices the department of health (dh) today (may 3) drew public attention to a safety alert issued by a local medical device supplier, roche diagnostics (hong kong) limited, on the potential for three of its blood coagulation testing devices, namely coaguchek xs, coaguchek xs plus and coaguchek xs pro, failing to show high results of international normalised ratio (inr). according to roche, which reported the issue to the dh, the devices were designed with a system fail-safe mechanism that, when activated, would display an "error 6" message aiming at preventing the display of wrong measurements. however, roche has confirmed that in rare cases, this "error 6" message might be displayed instead of the actual inr values. this problem might occur in patients with very long coagulation times, i.E. high inrs, such as those receiving treatment with vitamin k antagonists in combination with antibiotics and/or chemotherapeutics. to date, one case out of about 672 000 coaguchek xs sold globally was confirmed to have such a problem while no case relating to coaguchek xs plus or coaguchek xs pro has been reported so far. a dh spokesman explained that missing the diagnosis of extremely long coagulation times might lead to delay in treatment, resulting in severe haemorrhage. patients are advised to consult their health-care professionals as soon as possible if an "error 6" message is repeatedly displayed. in addition, roche will update all package inserts of the coaguchek xs pt test strips for the three devices with a label highlighting the "error 6" information and corresponding actions. according to roche, some 270 units of coaguchek xs were distributed locally to hospitals, clinics, health-care organisations, retailers and home users. three units of coaguchek xs pro were distributed to local hospitals. "the dh has not received any local report of adverse events arising from the use of the affected devices," the spokesman remarked. roche has set up two hotlines on 2485 7596 and 9534 6020 to answer public enquiries on this issue. "patients feeling unwell or in doubt when using the affected devices should consult their health-care professionals for advice as soon as possible," the spokesman advised. the dh has informed relevant stakeholders about the alert and shall continue to liaise with roche on the cause of the problem and follow-up actions. ends.