The initial reporter received a questionable high elecsys vitamin d assay gen 2 result for one patient from cobas e 801 module serial number (b)(4).The initial result was 77.4 ng/ml and the repeat result was 5.56 ng/ml.The erroneous result was not reported outside of the laboratory.There was no allegation of an adverse event.Roche diagnostics has issued an urgent medical device correction for this issue, entitled "elecsys® vitamin d total ii assay ¿ non-reproducible false high results." this correction has been reported to fda.During the implementation of the elecsys vitamin d total ii assay on the modular analytics e 170 module, and cobas e 601 and 602 systems, there were reports of non-reproducible, false high results.These customer observations were made in comparisons of duplicate measurements during assay validation of elecsys vitamin d total ii assay or in method comparisons with elecsys vitamin d assay (i.E., during conversions), where the falsely elevated discrepant value did not fit the expected result.The observed elevated results reported with the elecsys vitamin d ii assay were not confirmed upon repeat testing of the affected samples.The observed findings: the first result is elevated, either above the upper end of the measuring range (>100 ng/ml or >250 nmol/ml), or within the measuring range; repeated results are significantly lower.Rare cases have been reported on the cobas e 411 analyzer and the cobas e 801 module.Roche is conducting investigations into the reported issue and has determined that the elecsys® vitamin d total ii assay is strongly affected by pre-analytical errors.The investigations have reproduced these findings when requirements for pre-analytical sample handling have not been met for plasma samples.Further investigations into the reported issue are ongoing.As a result, the pre-analytical sample quality and compliance to the tube manufacturer¿s specifications is very important to assure a high quality sample in order to minimize the risk of occurrence.Investigations are ongoing to determine the root cause of this issue.A workaround has been provided to customers.
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The qc recovery was within range at the date of the event.There is no indication for a generic reagent issue based on the data.The sample in question was serum, but further pre-analytical information was limited.The service engineer performed a decontamination and replaced the measuring cell.After the decontamination, the customer had no further issues.The investigation did not identify a product problem.The cause of the event could not be determined.
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