Mdr 1218996-2017-00038 addendum.Magellan's investigations have confirmed that extended incubation (ie overnight) of blood/treatment reagent mixtures at room temperature or incubation at high temperatures (ie, 60 c) improved test results for some blood specimens.Studies suggest the venous blood collection tube contributes to the low results as similar low results are not observed with capillary blood samples.Magellan is continuing investigations on to determine root cause of suppressed results with venous bloods.Current labeling indicates that venous samples should not be used on the leadcare system.Same device kit from customer could not be used.The lot 1312bu materials were from magellan inventory.Customer's inventory was exhausted.Late filing is part of magellan diagnostics, inc.Response to fda's 483 issued on 29jun2017.Complaint # (b)(4).Testing was all done on 22oct2017 and patient sample results for lcu vs esa vs icp-ms (in ug/dl) were all filled under one mdr.We will now be submitting separate mdrs for each individual patient result.Results: (lcu vs esa vs icp-ms).2 vs 10.5 [1218996-2019-00016], 3.8 vs 9.8 [1218996-2019-00017], 4.2 vs 8.7 [1218996-2019-00021], 2 vs 6.5 [1218996-2019-00022], 2 vs 6.6 [1218996-2019-00023], 2.5 vs 8.7 [1218996-2019-00024], 2 vs 6 [1218996-2019-00025], 15.6 vs 21.2 [1218996-2019-00026], 15.4 vs 20.6 [1218996-2019-00027].After further investigation it has been confirmed that some of the blood lead sample results are not considered reportable events.See the data below: 7.7 vs 14.6 [not reportable], 5.1 vs 10.6 [not reportable], 9.2 vs 16.1 [not reportable], 2 vs 4.6 [not reportable].
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