The customer complained of a possible biotin interference for 1 patient tested for elecsys tsh assay (tsh), elecsys ft4 ii (ft4 ii), elecsys t3 (t3) and elecsys anti-tshr immunoassay (anti-tshr) on a cobas 8000 e 602 module.This medwatch will cover anti-tshr.Refer to medwatch with patient identifier (b)(6) for information on the tsh results, medwatch with patient identifier (b)(6) for information on the ft4 ii results and medwatch with patient identifier (b)(6) for information on the t3 results.The patient has multiple sclerosis and has been taking higher doses of biotin (3 x 100 mg per day) for the past 6 months.The patient takes biotin each day at 8:00 a.M., 3:00 p.M.And 11:00 p.M.The patient sample in question was drawn at 8:30 a.M.On (b)(6) 2018.The patient didn't remember if he had taken biotin at 8:00 a.M.Or not.The customer performed a procedure on the patient sample to remove the biotin from the sample and repeated the sample.Refer to attached data for the patient results.No erroneous results were reported outside of the laboratory.There was no allegation that an adverse event occurred.The e602 module serial number was (b)(4).The patient sample could not be provided for investigation.Product labeling states that the anti-tshr assay is unaffected by biotin levels up to 10 ng/ml samples should not be taken from patients receiving therapy with high biotin doses (i.E.> 5 mg/day) until at least 8 hours following the last biotin administration.Since the sample could not be provided, the biotin interference could not be investigated.From the data provided, a general reagent issue can be excluded.The investigation did not identify a product problem.The cause of the event could not be determined.
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