MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FT4 III ASSAY; RADIOIMMUNOASSAY, FREE THYROXINE

Model Number FT4 G3

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/25/2021

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2021, a sample from the patient was tested using a cobas 8000 e 602 module at a preliminary investigation site.The ft4 iii result was >7.77 ng/dl.The sample was requested to be submitted for further investigation.

Event Description

There was an allegation of questionable elecsys ft4 iii assay results for one patient from cobas 8000 - cobas e 602 module (b)(4).(b)(6).The customer reported out the results to a physician.

Manufacturer Narrative

The investigation is ongoing.

Manufacturer Narrative

Sample from the patient was tested as part of the investigation.The ft4 iii result from a cobas e801 was 8 mg/dl with a data flag and using a cobas e411 was 10 ng/dl.The ft4 ii result using a cobas e601 was 8 ng/dl with a data flag and using a cobas e411 was 28 ng/dl the difference in the results could be explained by the different calibrations between the cobas e411 and the cobas e601.No significant change in signal values was observed in the samples with reagent with streptavidin blocking agent.With the three different ft4 assay generations (ii, iii and iv), similar very high ft4 values were generated.Further clarification of the discrepancy is not possible with the available methods and the current state of the art.The investigation did not identify a product problem.The cause of the event could not be determined.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination, and other findings.

• Brand Name: ELECSYS FT4 III ASSAY
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 12955823
• MDR Text Key: 285454637
• Report Number: 1823260-2021-03623
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K131244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: FT4 G3
• Device Catalogue Number: 07976836190
• Device Lot Number: 547168
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 85 YR
• Patient Sex: Male