Catalog Number 06437281190 |
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 10/31/2016 |
Event Type
malfunction
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Manufacturer Narrative
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This event occurred in (b)(6).Unique identifier (udi)#: (b)(4).
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Event Description
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The customer questioned results from 1 patient sample tested for thyrotropin (tsh), elecsys ft4 ii assay (ft4 ii)and elecsys ft3 iii (ft3 iii).The customer provided the patient sample for investigation.Of the data provided, erroneous ft4 ii and ft3 iii results were identified between the customer's e602 analyzer, an e601 analyzer used at the investigation site and an e411 analyzer used at the investigation site.The date of tests performed at the customer site is not known.The initial results obtained at the customer site were reported outside of the laboratory.This medwatch will cover ft4 ii.Refer to medwatch with patient identifier (b)(6) for information on the ft3 iii erroneous results.No adverse event occurred.The e601 analyzer serial number was (b)(4).The e411 analyzer serial number was (b)(4).The ft3 reagent lot number used at the investigation site was 152267 with an expiration date of 05/2017.The ft4 reagent lot number used at the investigation site was 168540 with an expiration date of 07/2017.The serial number for the customer's e602 analyzer is not known.
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Manufacturer Narrative
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Upon further investigation of the patient sample, a streptavidin interference was confirmed.This most likely caused the high ft4 ii and ft3 iii results.The reagent used to perform the tests contains streptavidin.This specific interference is addressed in product labeling.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings.
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Search Alerts/Recalls
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