MultiCareTM Analyzer/Lumiratek C 에 대한 현장 안전성 서한

Field Safety Notice

2017-09-07

Slovenia

AMPMDRS

Problem: in case of the measurement of crp and u-albumin items using the multicaretm analyzer/lumiratek c, the analyzer shows the result of “lo” first correctly, however, the result is recorded “hi” instead “lo” in the memory. so, stored results are display incorrectly in review mode. however, there is no problem with the first displayed results that are displayed first, except for the results stored. we have conducted an activity to identify the cause of this problem and confirmed that it is caused by a software bug in the analyzer. - potential risk to patient: the analyzer reads u-albumin concentration between 5.0-300mg/l, crp concentration between 3.0-150mg/l for capillary or venous whole blood sample and 3.0-120mg/l for plasma or serum sample. and if the test result is out of the measurement range, the analyzer displays ‘lo’ message or ‘hi’ message. in crp or u-albumin measurements, if the patient's measurement result is indicated as 'lo', which means that the concentration of the crp or u-albumin is low, at the same time the patient is normal. furthermore, it is less likely that a person who is considered to be a patient is likely to display the results of the 'lo' measurement. however, if the measurement result of 'lo' is displayed and you have confirmed it as the result stored in the review mode, incorrect diagnosis, prescription and treatment may be made. for example, antibiotics or kidney medicines may be prescribed to normal people. this can cause adverse drug reactions.