The customer complained of questionable elecsys tsh assay results tested on a cobas 8000 e 602 module and elecsys ft4 iii assay, elecsys ft3 iii, and elecsys anti-tshr immunoassay results tested on a cobas 8000 e 801 module for 1 patient sample compared to competitor methods.The e 801 serial number was (b)(4).The e 602 serial number was not provided.This medwatch will cover anti-tshr.Refer to medwatch with patient identifier (b)(6) for information on the ft4 iii results, medwatch with patient identifier (b)(6) for information on the ft3 iii results, and medwatch with patient identifier (b)(6) for information on the tsh results.The tsh result was 0.18 iu/l on the e 602 and 1.62 iu/l on the beckman dxi access.The ft4 iii result was >100 pmol/l on the e 801 and 16.73 pmol/l on the siemens centaur.The ft3 iii result was 17.1 pmol/l on the e 801 and 4.915 pmol/l on the siemens centaur.The anti-tshr result was >40 iu/l on the e 801 and <0.9 iu/l on the thermo fisher brahms kryptor.The results from the e 801 and the e 602 were reported outside of the laboratory and the physician questioned the results.There was no adverse event.
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The customer sent the patient sample to the manufacturer for investigation.The customer's ft3, ft4, tsh, and anti-tshr results were reproduced.The presence of an interfering factor was detected in the sample.This interference is documented in product labeling for the assay.The investigation did not identify a product problem.
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