Model Number TSH |
Device Problem
High Test Results (2457)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/10/2020 |
Event Type
malfunction
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Manufacturer Narrative
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This event occurred in (b)(6).Quality control was acceptable on date of patient testing.The investigation is ongoing.
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Event Description
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The initial reporter questioned high elecsys tsh assay and elecsys ft4 iii assay results on a cobas 6000 e 601 module.The customer provided questioned results for one patient.The patient¿s initial tsh result was 6.70 uiu/ml and ft4 result was 39.8 pmol/l.The initial results were reported outside the laboratory.The physician questioned the results due to the results not fitting the patient¿s clinical picture.The customer performed repeat testing with another analyzer, abbott, and recovered a tsh result of 4.41 mu/i and ft4 result of 20.6 pmol/l.The repeat results were determined to be correct and reported outside the laboratory.Cobas 6000 e 601 module serial number used for patient testing was (b)(4).This medwatch is for tsh.Refer to the medwatch with patient identifier (b)(4) for the ft4 assay.
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Manufacturer Narrative
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Based on the investigation, the customer's tsh result could be confirmed.A general reagent issue could be excluded and no interfering factor was identified against the tsh assay.The differences in tsh results between the roche and abbot methods relate to differences of the setups of the assays, the antibodies used and differences of the standardization materials and procedures used.The investigation did not identify a product problem.The cause of the event could not be determined.
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Search Alerts/Recalls
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