The initial reporter had switched from version one (1) to version two (2) of the elecsys anti-tshr (anti-tshr) assay on a cobas e801 module and noted that the number of samples with results of <0.8 iu/l had decreased.The initial results from version two (2) of the assay were reported outside of the laboratory where the physician requested additional testing.The customer performed a comparison between the different versions for 23 patient samples.Of this data, the results for one (1) patient sample were discrepant.The customer is not sure which results are correct.The 23 patient samples were submitted for investigation where the results for one (1) additional patient sample were discrepant.This medwatch will cover the anti-tshr version one (1).Refer to medwatch with a1 patient identifier (b)(6) for information on the anti-tshr version two (2) results.Refer to attached data for the results.The e801 module serial number at the customer site was (b)(4).The e801 module used at the investigation site was (b)(4).The reagent lots used were: anti-tshr v1 lot 485820 with an expiration date of nov-2021.Anti-tshr v2 lot 473426 with an expiration date of aug-2021 and, anti-tshr v2 lot 505102 with an expiration date of jan-2022.
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The initial report stated: "the e801 module serial number at the customer site was (b)(6)." the cobas 8000 core unit serial number was (b)(6).The serial number for the e801 module used at the customer site was not provided.Calibration and qc were acceptable.Only the initial run at the customer site were slightly elevated; all the following repeat results were comparable.The cutoff used in japan is 2.0 iu/l, therefore, all results were below the cutoff leading to the same clinical interpretation of 'negative.' most of the results were between <0.8 iu/l and 1.1 iu/l, however, some single results were slightly higher.All samples were below or near the limit of quantification (loq) which explains the deviations.Based on the data provided, the investigation did not identify a product problem.The cause of the event could not be determined.
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