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

Model Number FT4 G3

Device Problems High Test Results (2457); Low Test Results (2458)

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

Event Date 01/14/2022

Event Type  malfunction  

Event Description

The initial reporter received questionable elecsys ft4 iii results for one patient tested with the cobas e601 module serial number unknown.It is unknown if the questionable results were reported outside of the laboratory.The customer results for sample 1 were requested but not provided.Sample 1 was sent for investigation and tested on a cobas e602 module and an abbott architect analyzer.Sample 2 was sent for investigation and tested on a cobas e602 module.The investigation site e602 module serial number was (b)(4).The ft4 reagent used at the investigation site on the e602 was lot number 547168 with an expiration date of 31-may-2022.

Manufacturer Narrative

The investigation is ongoing.

Manufacturer Narrative

Further investigations of the samples were performed.The values measured at the customer site could be reproduced in sample 1.The ft4 value for sample 1 was slightly above the reference range of the assay, the tsh value was clearly above the reference range, and the ft3 values were below the reference range.Confirmation testing of sample 2 could not be performed due to low volume.Interference analyses of both samples were performed.An interfering factor against the streptavidin component and antibody/idiotype of the ft3 assay could be excluded.Investigations are ongoing.

Manufacturer Narrative

The investigation could not identify a product problem.The cause of the event could not be determined.The difference in ft4 values is most likely based on methodological differences.

• 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: 13479613
• MDR Text Key: 291948824
• Report Number: 1823260-2022-00317
• 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: 05/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FT4 G3
• Device Catalogue Number: 07976887190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2022
• Initial Date FDA Received: 02/08/2022
• Supplement Dates Manufacturer Received: 04/08/2022; 04/20/2022
• Supplement Dates FDA Received: 04/27/2022; 05/06/2022
• 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