|
Model Number TSH |
Device Problem
High Test Results (2457)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 08/30/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
Based on the data provided, a general reagent issue can be excluded.Assays from different vendors can generate different values.This relates to the overall setups of the assays, the antibodies used and, differences in reference materials/methods, and the standardization methodology used.The investigation did not identify a product problem.The cause of the event could not be determined.
|
|
Event Description
|
The initial reporter received questionable elecsys ft3 iii and elecsys tsh assay results for two patient samples with the cobas e 801 module serial number unknown.The customer reported the tsh results to a physician who asked for re-measurement of the samples.The samples were sent for an investigation and were tested on a cobas e801 module, cobas e602 module, cobas e 411 immunoassay analyzer, and a siemens centaur analyzer.The investigation site e801 module serial number was (b)(4).The e602 serial number was (b)(4).The e411 serial number was (b)(4).The tsh reagent used at the investigation site on the e801 was lot number 533569 with an expiration date of 30-jun-2022.The tsh reagent used at the investigation site on the e602 was lot number 504973 with an expiration date of 31-aug-2021.The tsh reagent used at the investigation site on the e411 was lot number 512561 with an expiration date of 30-sep-2021.This medwatch is for tsh.Refer to the medwatch with patient identifier (b)(6) for the ft3 assay.
|
|
Search Alerts/Recalls
|
|
|