Catalog Number 07976836190 |
Device Problem
High Test Results (2457)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/04/2018 |
Event Type
malfunction
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Manufacturer Narrative
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This event occurred in (b)(6).
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Event Description
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The customer complained of high results for multiple patients tested for elecsys ft4 iii (ft4 iii) and elecsys ft4 ii (ft4 ii).The customer thinks there may be an interfering factor affecting the results which do not correspond to the patient's clinical picture.The customer states they are receiving high ft4 iii and high ft4 ii results for patients with normal thyroid function and normal tsh results.The high ft4 iii results were reported outside of the laboratory with a comment that there may be an interference.It is unclear if the ft4 ii results were reported outside of the laboratory.(b)(4).The customer provided data for 25 patient samples tested between (b)(6) 2018.Refer to attached data for the patient results.There was no allegation that an adverse event occurred.The cobas 8000 e 602 module serial number was (b)(4).
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Manufacturer Narrative
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It was clarified that the ft4 ii results were reported outside of the laboratory until (b)(6) 2018.After (b)(6) 2018 the ft4 iii results were reported outside of the laboratory.
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Manufacturer Narrative
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The customer stated that none of the affected patients are taking thyroid medication.The customer provided gender and the birth year for 23 of the patient samples.Refer to attached data for this information.
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Manufacturer Narrative
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23 of the 25 patient samples were submitted for investigation.The customer's high ft4 ii and ft4 iii results were reproduced in 20 of the 23 patient samples.3 patient samples showed ft4 iii results within the reference range.20 samples were tested for an interfering factor.An interfering factor that reacts with the reagent was confirmed in 1 patient sample (patient sample 8).This caused the high ft4 ii and ft4 iii results for this patient.Product labeling states "in rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin or ruthenium can occur.These effext are minimized by suitable test design." an interfering factor was not identified in the other 19 patient samples.The 23 samples were sent to an external laboratory for testing by the siemens centaur method.The ft4 results from the external laboratory were increased or close to the upper limit of the respective normal reference range, confirming the ft4 ii and ft4 iii results generated by the roche method.Product labeling states "for diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings." the investigation was unable to determine a definitive root cause.
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Search Alerts/Recalls
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