Siemens healthcare diagnostics, inc.Has confirmed that the atellica ch 930 module may report incorrect serum indices for hemolysis (h) and lipemia (l) when using the un_c test as a donor method, and the hemolysis icterus lipemia (hil) function is enabled.Due to bubbles in the reaction cuvette, there is a potential for falsely depressed 'h' results (e.G.H index of 3 or higher, reported as less than or equal to 1 ) at a rate of 0.3-1% and falsely elevated 'l' results (e.G.L index of 0 reported as more than or equal to 1) at a rate of 2.9%.In all cases of falsely depressed h, l is elevated more than or equal to1.For samples not using un_c as the donor method the indices are not impacted.An urgent medical device correction (umdc) asi19-02.A.Us was sent to us customers and an urgent field safety notice (ufsn) asi19-02.A.Ous was sent to ous customers in july 2019.The umdc and ufsn advise customers who have multiple atellica ch 930 analyzers to generate un_c results on a different analyzer than the hil tests.For customers who have only one atellica ch 930 analyzer when un_c is part of the test order and alt and ast are not, hil tests should be ordered separately, or alternatively hil ordering can be turned off.
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The customer initially alleged two discordant, falsely elevated lipemia (l) indices were obtained when using atellica ch 930 module.The initial indices were flagged incorrectly and were reported to the physician(s).Observation found the samples to be visibly clear, not lipemic.The repeat indices from the same atellica ch 930 module were correct and were reported to the physician(s).Later, the customer alleged multiple additional discordant, falsely elevated hemolysis (h), icerus (i), and lipemia (l) indices were obtained on atellica ch 930 module on multiple days.The additional results provided by the customer were not clear.
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