The initial reporter stated they have started using the elecsys vitamin d gen.3 assay (vitd g3) on their cobas 8000 e 602 module.After switching to this reagent from the elecsys vitamin d gen.2 assay (vitd g2), the customer noticed a negative shift in their third party controls and a positive shift in roche controls and proficiency samples.Patient samples were tested using both assays and a positive shift was seen in patient samples tested with vitd g3.Data was provided for six patient samples which had result discrepancies between the vitd g2 and vitd g3 assays.It was asked, but it is not known if any incorrect results were reported outside of the laboratory.This medwatch will apply to the vitd g2 assay.Please refer to the medwatch with patient identifier (b)(6) for information related to the vitd g3 assay.The serial number of the e 602 analyzer is (b)(4).
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Of the provided quality control data, roche controls tested with the vitd g3 assay were within range.Third party control recovery for the vitd g3 assay was also provided and higher imprecision could be seen on the lowest control level.Based on the provided control data, there was no indication of a general reagent issue.The investigation could not identify a product problem.The cause of the event could not be determined.
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