ProTime3 Test Cuvettes 의 안전성 경고

Safety alert

2012-10-24

2012-10-24

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20121024b.html

Medical device safety alert: international technidyne corporation protime3 test cuvettes the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning certain lots of protime3 cuvettes [product codes: pro3-25 and pro3-50], manufactured by international technidyne corporation (itc). during product performance surveillance itc has determined that some protime3 test cuvettes (pro3-25 and pro3-50) within the specified lot range may recover lower than expected prothrombin time/international normalized ratio (pt/inr) results. the manufacturer’s investigation into the product’s performance identified increased imprecision in addition to an increased negative bias, the combination of which may manifest as lower than expected pt/inr test results. management of warfarin therapy may have been affected for patients whose dosing regimen was determined solely using results from the affected cuvette lots. a low bias in patient pt/inr results with protime3 cuvettes that goes undetected by a laboratory may contribute to sub-optimal warfarin therapy, which may lead to a haemorraghic event and the potential for serious injury in some patients. four adverse event reports have been received by the manufacturer; no permanent injuries or deaths were associated with these reports. the manufacturer advised users to stop using the affected lots and remove from inventory for return to the supplier and to take the following actions. for patients tested with the affected protime3 lots, the pt/inr record should be reviewed and inr trends evaluated to determine if a repeat test is warranted. if a repeat test is required, the manufacturer recommended that it be conducted either by using an itc protime5 cuvette or a reference laboratory. it is advisable for users to conduct this review and follow up with their patients as soon as practicable. for details, please refer to the mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con195873 if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 24 october 2012.