Catalog Number 06437281190 |
Device Problem
High Test Results (2457)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 08/25/2015 |
Event Type
malfunction
|
Manufacturer Narrative
|
This event occurred in (b)(6).
|
|
Event Description
|
The customer questioned results for 1 patient tested for ft3 - free triiodothyronine (ft3 iii).The patient was brought to the hospital from a neurosurgery clinic.Due to the high ft3 iii test results, she was sent to endocrinology too.Based on the data provided, erroneous ft3 iii and free thyroxine (ft4 ii) results were identified between the customer's modular analytics e module and an outsourced laboratory test using the clia method.It is not known if erroneous results 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.(b)(6).No adverse event was reported.The modular analytics e module serial number was (b)(4).The customer thinks there may be a possible interference in the sample.
|
|
Manufacturer Narrative
|
It was clarified that the customer uses an e601 analyzer with serial number (b)(4).It was clarified that the outsourced laboratory test was from an architect instrument.The customer provided 2 additional samples from this patient tested for thyrotropin (tsh), free thyroxine (ft4 ii) and ft3 - free triiodothyronine (ft3 iii) for investigation.The new sample dates were (b)(6) 2015 and (b)(6) 2015.Of the data provided, no erroneous results were identified for these tests.
|
|
Manufacturer Narrative
|
The sample was submitted for investigation.A specific root cause could not be identified.The ft4 ii results were within the reference range.
|
|
Search Alerts/Recalls
|